Extract from
my Bok: for Group members: CHAPTER – IV(Final)
Intrauterine
Devices: Intrauterine contraceptives:
(Contraceptive Coil)
INDEX
Basics of IUDs – P, Type of IUD – P, Information on string of IUD – P,
Brand names & Life span – P, Mode of Action – P, How soon become effective
– P, Contraceptive efficacy – P, Users satisfaction & Continuation Rate –
P, Advantages as contraceptive – P, Side effect and their management – P,
Disadvantages as contraceptive – P, Candidacy for IUDs – P, Who criteria &
Checklist – P, IUD & Timing of insertion – P, Insertion Procedure – P,
Follow up – P, When to remove (Indications for removal) – P, Procedure of
removal – P, Switching to some other method – P, Return of fertility – P,
Complications, Health Risks & warring – P, Skill of HCP – P, Pill or IUD which
one to choose – P, LNG IUS or copper beaing IUD – P, Conclusion – P, Further
Reading – P, Webs – P.
The basics of IUDs:
An IUD (also
called IUC) is a small ‘T-shaped’ flexible plastic device that is inserted
inside the womb (uterus) through birth canal to avert pregnancy (Fig-1). It is
the world’s most widely used reversible birth control method for women. The
letters ‘IUD’ stands for “Intrauterine Device” and IUC is for intrauterine contraceptives. Both
abbreviations are for the same device. The ‘contraceptive coil’ or ‘loops’ are
just other names for the same contraceptive. Earlier it was used to be called
as IUCD i.e. intrauterine contraceptive device. Globally the present
abbreviation is IUD and only in some countries it is called IUC.
IUD is an easy,
convenient, highly effective form of contraception that does not interfere with
sexual spontaneity. Once introduced the
IUD is immediately effective. It can also be used as emergency
contraceptive i.e. as after sex conceptive if the IUD is
fitted within seven days of unprotected sex. The sooner the device is fitted
after unprotected sex more will be the contraceptive efficacy.
Not all IUDs
are alike. There are several types, and they come in different sizes and
varying shapes. Like other drugs and devices there is long history of its
evolution and hundreds of IUD have been tried in last two centuries. Readers
will be surprised to know that the idea of putting some device inside the womb
to prevent conception initiated with contraception camels. Camels frequently
undergo long journey in the desert. To avoid pregnancy during this long voyage
some pebbles (stone like material) used to be inserted in the womb of camel.
Thus the camels did not fall sick in the voyage.
Basically
there are two types of IUDs. One is copper
impregnated IUDs which when fitted inside the womb release copper ions and
other one is progesterone hormone
containing IUDs which releases in sick the womb. It is the released copper
or progesterone which effect contraception though plastic frame itself has some
contraceptive effect. Copper bearing IUDs have proven the test of time and most
popular form of IUD. In fact, there is a museum which exhibits over 300 IUD
designed over two centuries collected from different countries.
Copper
containing IUDs are the most inexpensive long-term reversible method of
contraception. It can be removed at any time and fertility resumes within
couple of months. The IUD requires no daily attention and this is the distinct
advantage over contraceptive pills, or condom. The only responsibility of the
acceptor is to confirm the placement of IUD after each menstrual period by
feeling the thread of IUD which hangs in the upper part of birth canal. The
thread is tied to the lowermost part of the device.
Like other
contraceptives it has its own limitations and disadvantages. For instance, IUDs
must be inserted and removed by a health care professional. It should never be removed by the client
even if the thread is easily palpable. Occasionally the device causes menstrual
irregularities and cramps in the lower part of belly (uterine cramps). Rarely
there can be spontaneous expulsion of the device through birth canal
particularly during excessive straining at defecation.
Principal Types of IUDs:
Classification of Medicated
IUDs: All modern IUD
contain some active sustances either in the form of metal (e.g. copper) contain
synthetic progesterone hormones. So modern IUDs are called medicated IUDs. Unmedicated i.e. only plastic devices are less
effective. Though these were once popular in the decade sixties and seventies
are no longer used nowadays.
Classification of Medicated IUDs:
Medicated
IUDs are of two types
a) Copper bearing IUDs and b) Hormone releasing IUDs. First group and most
widely used is copper bearing IUDs
has a band of copper (either in the form of wire or sleeve) worn around the
plastic device. This type of copper bearing device can be kept inside the womb
for 3-14 years depending upon the copper content. The most popular copper
containing IUD is T-cu-380A which
when fitted is effective for fourteen years. In U.K. & U.S.A. it is sold
under the brand name of ‘PARAGARD’.
The second group is hormone containing
IUDs which contains a special hormonal reservoirs from which small amount
of female hormone called ‘progesterone’
is released daily inside the womb and effect contraception.
This second
group of IUDs again is of two types depending upon the type of progesterone
used. If ‘pure progesterone’ is used then it has to be replaced annually. Such
device is available in the market under the trade name Progestasert but for varying reasons it is no longer used and it
was never been available in Indian market.
The other
type of hormone containing IUD is impregnated with ‘levonorgestrel’ type of progesterone. This relatively newer type of
hormonal IUD is gaining popularity at a very fast rate because it has the
ability to ameliorate variety of gynecological diseases in addition to
contraceptive effect. Fortunately it has become available in India since 2002
(under the brand name Mirena IUS Fig.-2). Scientists often call it ‘LNG-IUS’ or
LNG-20. The word LNG- stands for ‘levonongestrel intrauterine system’. In
this book the word ‘LNG-IUS’ will be used to mean this type of hormone
releasing IUD. The contraceptive efficacy of this IUS lasts for five years.
Many other
IUDs which were used in the twentieth century are no longer used. These are
safe coils, Lippes loop, Dalcon Shield, Cu-7. The modern copper IUDs however
are safe, effective and inexpensive method of achieving reversible
contraception in properly selected women.
Most copper
medicated IUDs have an abbreviation depending on the design of the frame and
exposed surface area of copper wire. For instance the most commonly used copper
containing device is abbreviated as T-Cu-380A which means the shape of the
device is ‘T’, and the exposed copper wire winded around the device is 380
sq.mm. In fact this copper wire is winded both in vertical limb as well as on
the collar i.e. transverse bar of the plastic device.
Remarks on the string of IUD:
As mentioned
earlier the only commitment of the client after the IUD is fitted is to cheek
the presence in the upper part of vagina at monthly intervals. Thus it is
worthy to know few relevant points pertaining to the string attached to IUD.
Both copper
medicated and hormone containing IUDs have one or two ‘filaments’ or ‘strings’ –
that is threaded through a hole in the bottom of the vertical arm of the device
which is shaped as T (sig. Fig.-3). The strings are tied in the device with a
knot and strings hang through the lower opening of the cervix into the upper
birth canal. The string is monofilament i.e. a single strand of strong plastic.
Contrary to popular belief, this thread which hangs in the birth canal does not
absorb fluid from birth canal neither transmits bacteria up into the womb. The
partner do not feel the thread during lovemaking process neither the male organ
is hurt by the thread.
The string
has two purposes. It is primarily meant for easy removal of the device with the
help of an instrument called ‘artery forceps’. The string also gives an
opportunity to the woman clinician to know if the IUD is still in the correct
position i.e. inside the womb. As said earlier, the women or her husband should
periodically check (once a month is sufficient) its presence by touching the
string. It is best palpated in squatting position or else woman can put one
foot on a low tool and then insert her index and middle fingers in the birth
canal. It should be searched more in backwards than upward direction. Usually,
the thread is readily palpable. If not, then one can put her fingers up in the
birth canals. When she will be able to feel cervix which feel like tip of nose
with a small hole i.e. depression at centre. Some amount of mucus is easily
felt at this part and it is in this portion the string should be searched.
If the string
seems to shorten or lengthen, the IUD it may mean that have moved up inside
then womb or has come down. This mandates an ultrasonography (imaging the womb) to verify correct location of IUD
in relation to longstudinel axis of womb (uterus).
If the string
can’t be located at all it may mean that IUD has expelled spontaneously
possibly without the knowledge of the acceptor. On very rare occasion device
may have perforated the womb and travelled to tummy (abdomen). In summary the
purpose of putting a sting in IUD is as follows –
a)
It
satisfies the client that the IUD has not fallen off the body.
b)
It
helps in easy removal of IUD.
c)
If
there is there is lengthening or shortening of thread then it implies that IUD
has either come down from womb or has coiled up in the womb.
Brand Names:
A) Copper bearing IUDS:
1)
‘Multiload cu 250 (ML-Cu-250) and
Multiload Cu-375 (ML-Cu-375): The intrauterine life
span of such IUDs is 3 and 5 years respectively. The cost such IUD in Indian
market.
i)
Multiload
IUDs - Multiload IUDs have curved flexible arms with spurs. These spurs seek
anchorage to fundus, thus reducing expulsion rate. Copper wire on the stem is
worn around vertical limb of T and two popular designs are with 250 mm2
and 375 mm2 surface area of copper. Multiload 250 has lesser side
effects. While Multiload 375 is as effective as Tcu-380A.
ii)
T Cu 380A – Tcu-380A has solid copper sleeves on transverse arm and coil of copper wire
around the stem. This is a highly effective copper device with efficacy as high
as 99%. By adding silver to this (TCu-380 Ag), efficacy has further improved
with a failure rate as low as 0.7%. This is available abroad under the brand
name of Paragard or T-safe-Cu 380A. The name paragard was
used as its use was initially restricted to porous women only. This device was
approved by FDA (Food and Drug Authority of US) in the year 1984. In India it
is sold in open market under the brand name of “NUGUARD 380A” & T-Cu-380A
is the other name distributed by Govt. of India free of cost through all Govt.
hospitals.
Globally two types of
Copper IUDs e.g. T-Cu-380A and ML-Cu-375 are the most commonly used
copper medicated IUDs which is there are about dozen of other copper bearing
IUDs still popular in different parts of the globe. These are Cu-7, T-Cu 200,
T-Cu 220C, T-Cu 220B, Cu Nova T, T-Cu 200C. These are not popular in India and
neither they are readily available in all the provinces of India.
B) Hormone bearing IUDs:
1)
IUDs impregnated with progesterone
hormone: ‘Progestasert’ is the brand name and these
have life span 1 year only – As stated earlier the devices are rarely used
now-a-days. This is not available in India.
2)
Device containing levonorgestrel
hormone: This device is available under the brand names
of ‘LevoNova’ or more commonly ‘Mirena’ (intrauterine dwelling time 5 years).
Instead of IUD scientists often call it as IUS (Intrauterine System). This
device is manufactured by Bayer Healthcare Pharmaceticals, Wayne, New Gersey.
It is marketed in India by German Remedies and the approximate cost in India is
Rs. 6000/-.
There are some newer IUDs which has become available recently:
In the last
two decades some newer IUDs has come in the market. They are ‘T-safe-Cu-380A’, ‘Gynae-fix’, ‘NOVA T’,
‘Flexi-T-380’, ‘Fibroplant IUS’. These are used with varying degree of
satisfaction. Sadly, such modern IUDs
are not available in our country. Which brand of IUCD to choose?? he brands are T Cu 380A::, ML Cu 250
ML:: Cu 375 ML , These three brands are most popular in our country.and choiced
by acceptors & provider. .. There is little to choose about efficacy and
side effects as those side effects are related to A) Inappropriate case
selection(wrong method selection by acceptor/ Contraceptive provider),Most imp
index of side effects like A) , perforation,B) spontaneous expulsion C) pelvic
pain unrlealed to periods D) Dysmenorrhoea E) ,BTB
F) Preg with IUCD in situ-uterine / Ectopic are related to proper fitting of
the device in uterus -Fundus seeking device is most important., here are some
newer IUDs which has become available recently:
In the last two decades some newer IUDs has come in
the market. They are ‘T-safe-Cu-380A’, ‘Gynae-fix’, ‘NOVA T’, ‘Flexi-T-380’,
‘Fibroplant IUS’. These are used with varying degree of satisfaction. Sadly,
such modern IUDs are not available in our country. There is little to choose .
I personally advocate Govt supply T Cu 380A which is effective for 12 yrs
(dwelling time). ew brands of copper wire woven IUCD are 1)Prega-T Cu
380A2) Care Cu 375 / 250 3) Trust Copper 380A 4) Khushi - T Cu 380A / 375 5)
Fredom 5 - Cu 375 .Good old copper IUDS used in the decades of seventies and
eighties were Cu 7, Cu T 200 ,Nova T, T Cu 200 C, T safe Cu..Currently for PP
insertion people are using Gynae Fix PP & after abortion GynaecPA..The
efficacy ,side effects, compl all depends on the driver ( who fits the device in
womb) .no fault with thr Car ( women concerned).To conclude a survey among lady
doctors of US reveled that as many as 60% are using Copper device after one
child birth.
Why newer devices?
For
last several decades modifications of size, shape and chemical content are
being aimed at to reduce the expulsion rate of side effects while maintaining
the exceptionally high effectiveness and safety profiles of IUDs. Reproductive
scientists are working on different frame designs too. In the process frames of
different sizes and shapes with various active substances incorporated in the
frame for pregnancy prevention has been made available. Some are still in newer
clinical trial phase. Hopefully, IUDs will bring many more options for
fertility regulation. The uterine cavity has a hollow space. However, in
reality, this space, which varies in size and shape peculiar to each woman, can
better be described as a potential cavity that widens at the tubal openings.
The area adjacent to the tubal openings is often described as being overly
sensitive for irritation, and hence, leads to increased uterine contractions
when IUDs are fitted. So scientists are trying hard to design such IUDs
which will minimize repeated trauma in these parts of uterus i.e. the most
sensitive parts.
As
on in 2004, Chinese women had 21 types of IUCs to choose from. Examples of
research on in IUC include smaller less bulky devices intended to geometrically
adapt to smaller nullparous uteri, frameless copper IUDs fixed to the
endometrium with a thread, devices with movable joints in the cross bars to
help them expand and contract with uterine contractions and adapt to different
uterine sizes and contours (geometric adaptation). Some newer devices have
cervical components and cervical anchoring systems. Still smaller devices
appropriate for the smaller atrophic perimenopausal uterus are also under
clinical trial. For detailed information on newer devices reader is requested
to refer appendix.
IUD acceptability: IUD use by Indian women:
There were
three National Family Health Survey in India. The study period were 92, 93, 98,
99 and 05, 06. The contraceptive use amongst married women aged 13-49 years and
% as per NFHS I, II & III. In these survey it was revealed that %, % and % of women used IUD.
IUD use in other Countries:
Almost 156
million married women of reproductive age worldwide use IUD. Amongst all
married women who use any family planning method as many as 20% rely on IUD.
Copper IUD is
very popular In China and 92 million of Chinese women are wearing copper IUDs.
Globally sixty percent all IUD users live in China. In China 83% of married
women use some form of contraceptive. This is commonly expressed as CPR i.e. Couple Protection Rate. Thirty six
percent of them use IUD!!!
IUD is also
popular form of contraceptive in Egypt, Mongolia, Vietnam, North Korea &
Latin America particularly Mexico. Similarly this contraceptive device is also
popular in Eastern Europe, Finland and Norway. Ten to thirty percent of women contraceptors of those countries
use IUC.
USA doctors
prefer to use IUC for themselves! In USA though the prevalence amongst general
population is only 2% but the use amongst female physicians and female
gynecologists were 5% and 9% respectively. Female fellows of the American
College of Obstetricians and Gynecologists answered that would choose IUC as
their first choice contraceptive method when childbearing was completed and as
their second choice after oral contraceptives, if desiring to space their
children. US women who have the most knowledge to make their contraceptive
decisions i.e. obstetrician/gynecologists choose IUC more frequently than their
patients.
Mode of Action as Contraceptive:
The
way an IUD works as contraceptive is not fully understood. The most recent
studies however indicate that the very presence of an IUD impedes the movement of sperm inside the womb thereby
preventing fertilization of eggs. This action applies both to inert i.e.
nonmdeicated IUDs (not available nowadays) and modern medicated IUDs.
Additionally, copper released from copper containing IUDs disrupts sperm-oocyte
interaction. We know that union between sperm and ova which occur in egg
transport tube are depended on about dozen of enzymes. Released copper ions
impair the efficacy of such enzymes involved in the fertilization process. Thus
copper IUDs acts prior to fertilization and thus it is not an abortificient per
se. Copper ions which diffuse from the copper bearing IUDs also damage the
spermatozoal enzymes system and other enzymes present in the womb necessary for
blastocyst (future embryo) inplantation. In contrast to oral pills neither
copper bearing IUDs nor the hormone containing IUDs alter ovary and function
and suppress release of eggs.
In
summary, the main effect of copper IUDs is prevention
of fertilization and even if fertilization occurs there is ‘implantation blocking effect’ which acts
as a back-up contraceptive mechanism.
Effectiveness or Reliability of IUD as contraceptive:
Modern IUDs
are very effective in preventing
pregnancy. The first year failure rate for the copper IUDs is about 1.5 to 0.8
%, which is slightly higher than that of tubal sterilization (0.5% in the first
year). The efficacy of this device can be compared favorably with ‘combined’
pills (first year failure rate 0.1%) and progesterone only pill (first year
failure rate of 2%). Fortunately, the failure rate for copper IUDs appear to be
highest in the first year and declines thereafter. Similarly pregnancy rate in
first-year perfect users are 0.8 to 0.6 and 0.1 per 100 women, in LNG-IUS users
and Copper T380A users respectively.
Life span of IUD: Intrauterine Dwelling Time: How long an IUD is going to
offer contraceptive protection after it is fitted in womb?
International
agencies differ on this issue so also the Drug Controller Authorities of
different countries. It will be prudent for the HCP to strictly follow
guidelines approved by the country in which he/she practices. For instance
Govt. of India recommend 10 year intrauterine efficacy of T-Cu 380A device (the
most popular IUD) though WHO has declared that the particular IUD is effective
for 14 years without any loss of contraceptive efficacy. The life span of other
two commonly used copper IUD e.g. Multiload Cu 375 and ML Cu 250 are five year
and three years respectively. These two IUDs are freely available in Indian
market.
Continuation Rates & Clients Satisfaction:
Women spend most of their
reproductive years on average 30 years trying to avoid pregnancy. Thus the
impact of continuation rates on contraceptive success cannot be underestimated.
IUC demonstrates high contraceptive effectiveness and it has high biologic efficacy.
It requires almost no compliance. In fact it takes a volitional act to
discontinue protection rather than to use protection. IUD has the highest
continuation rate of any reversible method.
The copper
IUD continuation rate is 78%, and the LNG IUS continuation rate is 81% at the
end of first Year of use. In contrast, oral contraceptive continuation rates at
1 year range from 50% to 68%. Although the efficacy of depo-provera is
considered top-tier, the overall continuation rate at 1 year is only 56% and is
as low as 22% in some populations.
Although
continuation rates with the two IUDs are similar, reasons for discontinuation
differ. More women discontinue the copper device because of bleeding and cramping complaints,
whereas more women discontinue the LNG-IUS device because of amenorrhea (stoppage of menstruation)
and hormone related side effects.
Overall, continuation rates are similar.
E) Advantages of IUDs as contraceptive: Why woman will opt for IUD?
1)
Immediately
effective and very little to remember subsequently.
2)
Can
be used during breastfeeding. Does not alter the quantity of breastmilk.
3)
A
single decision leads to effective long term prevention of pregnancy. IUD is a
long acting contraceptive, therefore often called as ‘forgettable contraceptives’.
4)
T-Cu
380A is distributed at no cost by Govt. of India and available even in remote
rural areas e.g. PHCS, BPHCS (Block Primary Health Centers).
5)
Less
follow up to clinic. The contraceptive induced side effects after six months
are minimal (worry free contraceptives).
6)
Requires
no attention except for monthly checks for the string (to be done by
self/husband).
7)
Does
not interrupt sex. Efficacy of this method is very high, so increased sexual
enjoyment because there is no need to worry about pregnancy or contraceptive
failure.
8)
Fertility
resumes immediately upon removal.
9)
There
are no hormonal side effects with copper bearing IUDs. In fact there are no
systemic side effects like oral pills, hormonal injections, implants or
transdermal patches.
10)
There
is no interaction with any drugs.
11)
There
are certain ailments or diseases where oestrogen hormone use is
contraindicated. Such women should avoid combined oral contraceptives which
contains oestrogen hormone. Fortunately most of them can use copper IUDs which do not contain any hormones whatsoever.
The clinical conditions when oestrogen hormone should be avoided are:
List
of such clinical situations where IUD can be safely used are 1) Heavy smokers
and or obesity 2) Diabetes mellitus of all severity. 3) Benign breast diseases
4) Migraine (IUD can be used in all types of migraine). 5) Controlled high
blood pressure if BP is upto 160/100 or even beyond 6) Thrombophilia i.e. blood
coagulation problem e.g. women with past history of deep vein thrombosis may be
fitted with IUD. 7) Past history of stroke 8) Gall bladder diseases 9) Varicose
veins 10) Ischemic heart disease 11) Hyperlipidaemia (excessive bad cholesterol
in blood) 12) uncomplicated valvular diseases of heart in absence of pulmonary
hypertension and atrial fibrillation (to be fitted with the consert of
cardiologist) 13) Depressive disorders 14) Women suffering from tuberculosis
provided tuberculosis is outside the genital organs (e.g. non pelvic
tuberculosis) 15) Diseases of the mouth of womb i.e. cervix. These are often
called CIN (cervical intraepithlial neoplasia) & ectropion of cervix.
Copper
bearing IUDs however can be safely used in above quoted conditions provided if
she does not have concomitant diseases of womb e.g. tumors, or descent of
genital organs or infections. These diseases of womb may make the client
unsuitable for IUD use. Thus HCP coming across such women with above quoted
‘systemic or general diseases seeking contraception may be motivated for using
copper IUD as first choice contraceptive and women should be counseled and made
aware of relative safety of IUD. Such counseling should preferably be done both
during antenatal visits and also during postpartum visits.
Covert use of IUD:
Husband
and some family members often do not approve contraceptive used, particularly
in rural India. This is a complex social issue involving gender inequality and
woman’s control of their own health and fertility no pane.
This
is often nowadays called ‘altitudinal
factor’ for any social problem and not limited to contraceptive non use
only. Fortunately, this contraceptive device can be used without the knowledge
of the husband and family members. In some societies social norms many make it
difficult for a woman to discuss sexual matters with her husband or adoption of
methods that control her fertility. This not only true for rural Indian women
but for slum dwellers too. This particular long-term contraceptive may be used
without the permission of husband. Covertly quarterly shots (total four doses
of injection per year) can also be taken without disclosing to her husband
provided the wife is motivated.
In summary there are three special situations
where copper IUD surpasses all other contraceptives. Firstly, it can be used in
a variety of medical diseases where hormonal contraceptives are contraindicated
and may be harmful to client. Secondly, once fitted it will offer contraceptive
protection for 12-14 years with virtually no follow up. Thirdly IUD is used
covertly without the knowledge of husband and family members. It can also be
used soon after birth (puerperal insertion of IUD) or it can be fitted after
six weeks of childbirth without affecting breast-milk production.
Candidacy for IUDs i.e. selection of acceptors: Who are the ideal women
for IUD? The most
ideal women for IUDs should have following characteristics:
1)
Have
had children but do not wish to have more by another 3-4 years time. It is not a good contraceptive where short
term contraception is planned.
2)
Have
no history or clinical evidence of pelvic infection e.g. pelvic pain, white
discharge or dyspareunia etc.
3)
Have
no history of sexually transmitted infections (S.T.I.).
4)
Have
only one sexual partner.
5)
No
uterine tumor or distortion of womb.
6)
No
dysmenorrhoea or menstrual irregularity.
IUD can be used
in women who had ectopic pregnancy earlier. The absolute risk of ectopic
pregnancy is extremely low due to high effectiveness of IUDs. However when a
woman becomes pregnant during IUD use, the relative chance of ectopic pregnancy
as compared to uterine pregnancy is considerably increased.
Poor candidates for IUDs: Contraindication of IUD as a contraceptive:
a)
Recurrent or current pelvic infection (PID). This is the most important
contraindication for IUD use. But IUD can be used if there is one pregnancy
after an attack of PID and there is no
risk of acquiring S.T.I.
b)
behavior
of the acceptor or her husband is so that there is a fair chance for acquiring sexually transmitted disease.
It any of the spouse has multiple sex partners then ideally sexual copper
bearing IUD should not be fitted. Hormone containing IUDs may however will be a
better option.
c)
Those
who are already suffering from menstrual
cramps and/or heavy periods. Hormone containing IUC (Mirena) may be
beneficial in such women. Such IUD will serve the dual purpose of contraception
and disease transmission.
d)
Similarly
those who are suffering from abnormal
bleeding or anemia are also not good candidates for IUD.
e)
Part
history of ectopic pregnancy: It is better to avoid IUD for those group of
women though opinion differs. Now only a few gynecologists believe that IUD
should not be fitted in such women.
f)
Uterine Fibroids hormone containing IUDs may however
be used. According to WHO if myomas do not distort the uterine cavity then
copper IUD may be used if no other suitable contraceptive is available?
g)
A
very large/small uterus and other anatomical abnormalities of womb.
h)
Obvious
cervical or uterine cancer.
The assessment of suitability of IUD is done in stepwise manner. e.g. -
1)
Replies
by the client in response to some question.
2)
Clinical
examination by the HCP.
3)
Laboratory
lists to desires exclude STI.
Checklist (question) for screening clients who to initiate Use of the
copper IUDs:
Intrauterine devices (IUDs) are generally safe and effective for use by
many women, including those who have not given birth, who want to space births,
and those who are at risk of HIV infection or living with HIV infection. But
some women are unsuitable for IUD due to the presence of certain female
diseases, such as current cervical infections (infections of the mouth of the
womb), PID or other diseases of womb (uterus). For these reasons, women who
desire to use an IUD must be screened for associated gynecological
conditions to determine whether if they are appropriate candidates for the IUD.
It no such screening is done prior to IUD insertion then post insertion
complications will increase considerably which must be avoided by all means.
The
checklist consists of a series of questions planned to identify any medical
condition or behavior that would either prevent safe IUD use or require further
screening in the form of investigation. As well as provide further guidance and
directions based on client responses. A health care provider should analyze her
response to all questions before inserting an IUD and thus assess eligibility
of IUD use.
Answers to be replied by prospective acceptor:
1)
Have
you given birth within the last 4 weeks?
IUD should be fitted after 4 weeks of childbirth and not before.
2)
Have
you been told that you have pelvic tuberculosis or any type of cancer in your
genital organs?
3)
Do
you have bleeding between menstrual periods that is unusual for you or bleeding
after sex?
4)
Within
the last 3 months, have you had more than one sexual partner?
5)
Within
the last 3 months, do you think your partner has had another sexual partner?
6)
Within
the last 3 months, have you been told you have an STI?
7)
Within
the last 3 months, has your partner been told that he has an STI or has he had
any symptoms for example, penile discharge?
8)
Are
you HIV positive?
9)
Have
you developed AIDS?
a)
If
answers to Q No. 3 are yes then it implies that she has probably some female (gynecological)
disease then she should be treated for that specific disease and IUD fitted at
a later data with the approval of gynecologist.
b)
If
answer to any of the questions 4 to 7 is affirmative then also IUD should be
avoided. IUD can be fitted after cure of suspected gonorrhea or Chlamydia
infection (STI)
c) If answer to Q 8 is yes and there is
no evidence of AIDS disease then she can use IUD.
d)
If
answer to Q. 9 is yes then IUD may be used if she is doing clinically well on
ARV drugs (antiretroviral agents). But if she is not on ARV then IUD should not
fitted.
Additionally,
no pregnant women should be fitted with IUD. Pregnancy can be excluded by home
monitoring of urine for pregnancy test after the expected date of period in
over. But occasionally such kit may not be available in remote areas of India.
Then putting the following questions to the acceptor can reasonably assess
whether she is pregnant or not. These questions will also give a possibility of
having pregnancy in the running cycle before the expected date. Pregnancy is
almost always impossible under the following situations.
1)
She
has abstained from sex since last period.
2)
She
has given birth in the last four weeks or she had an abortion in last two
weeks.
3)
The
baby is less than six months age, and she is fully or nearly fully
breastfeeding and has not resumed menstruation as yet (Lactation Amenorrhea
Method).
4)
Pregnancy
is also unlikely in the current cycle if she was using a reliable contraceptive
‘consistently and correctly'.
B) Pre-insertion clinical examination by the
HCP:-
1)
Is
there any ulcer on the vulva vagina or cervix?
2)
Is there purulent cervical discharge?
3)
Does
the cervix bleed easily when touched?
4)
Were
you unable to determine the size and/or position of the uterus?
5)
Is
there any ‘motion tenderness’ i.e.
movement of cervix does the client feel pain in her lower abdomen when one move
the cervix sideways?
C) Laboratory investigation to exclude STI:
Is it essential to screen all women for STI if she desires for IUC? Gonorrhea and Chlamydia are the too
common STIs which cause immense local damage in genital organs. There are many
other fatal and nonfatal STIs which do not primarily affect the genital tract
but cause damage of other parts of body e.g. syphilis, hepatitis B, HIV etc.
etc. So far as screening for fitness of IUD is concerned on should ?????? on
gonorrhea and/or Chlamydia only but screening for STIs should be individualized
to the patient population. For instance evidence does not support routine
screening for gonorrhea and chlamydia in populations
at low risk of STIs. Factors that indicate high risk include history of a
new sexual partner, age under 25, or recent history of STIs. If screening in indicated, it can be done at the
time of the insertion, and the patient can be called for treatment and
encouraged to employ dual form of protection IUC for pregnancy protection and
consistent condom use for STI prevention.
Side
effects and/or complications of IUD are minimal if the acceptors are properly
selected. Properly fitted IUD in eligible women rarely cause any annoying side
effects. Occasionally there can be missing of threads and irregular vaginal
bleeding with or without pelvic pain and only on rare occasion there can be
accidental pregnancy (uterine or extra uterine). Pelvic infection is also a
possibility which has been long debated. This is particularly time if the
couple dies not maintain a monogamous relationship. All these complicates are
discussed at length.
Timing of insertion: When to get an IUD fitted?
A)
With
no evidence of recent pregnancy –
a)
Within twelve das of commencement of menstrual period : A woman can be fitted with IUD
within first twelve days of commencement of menstrual bleeding. The device offers immediate protection
and no additional protection is required in that cycle even if she had
unprotected sex in that cycle prior to the insertion of IUD.
Probability of an existing pregnancy
is extremely low before day twelve of the menstrual cycle, based on the
extremely low risk of ovulation before day eight and the 5-to-7day emergency
contraceptive coverage effect of copper bearing IUDs.
b)
Any day of menstrual cycle : IUD can also be inserted at any time during menstrual
cycle at her convenience if she is reasonably certain that she is not pregnant
i.e. either she had no coitus in that cycle or had coitus with due protection
e.g. condom or were under cover of oral pills.
c)
During amenorrhea provided urine test for pregnancy is negative: Amenorrhea i.e. cessation of
menstrual period six months a beyond may be due to pregnancy, lactation or due
to some gynecological, endocrine or nor commonly psychological facts. IUD can
be fitted if amenorrhea is due to endocrine, psychological or local (uterine)
cause and no harm will result. But results from international clinical trials
do not confirm this belief and IUD insertion is quite safe six weeks after childbirth. The only care that HCP (Health Care
Providers) should exercise is that uterine size must be determined carefully by
bimanual examination and by passing a uterine sound (a thick flexible wire)
into the uterus. Because at this stage womb is often small, therefore, a small
sized IUD like ML Cu 250 (short), ML Cu 375 (short) or NOVA T (if available)
may be the better choice. Standard size IUDs may however be chosen in lactation
period, after resumption of menstrual period.
d)
Emergency
IUD insertion as post-coital contraceptive: Use of copper containing devices as
emergency contraception is safe and effective and can help prevent unintended
pregnancy if used within 120 hours of unprotected intercourse. Emergency
contraceptive pills (ECPs) containing only levonorgestrel are also effective
and have fewer side effects.
The advantages of the IUD as
a post coital method are its high efficacy and the fact that it can be used up
to seven days after coital exposure. For certain parous woman it is the method
of choice if the women desires to use the IUD as her angoing method of
contraception. At this time the women is highly motivation. It is particularly
appropriate for the parous women with a single sexual partner who is at a high
risk of pregnancy due to failure of a barrier method. It also is appropriate
for a woman who has been sexually inactive for some time and suddenly finds
herself in an unprotected and unplanned sexual relationship (source: OUTLOOK).
The efficacy of
copper-relasing IUD as emergency contraception is very high. It can reduce the
chance of pregnancy by more than 99% when inserted within 5 days after
unprotected intercourse.
This method may be
particularly useful when the client is considering its use for long-term
contraception and/or when the hormonal regimens are less effective because more
than 72 hours have elapsed. When using on IUD for emergency contraception, the
eligibility criteria are the same as those for regular use of these device.
Making emergency contraception more widely available can be an important step
in preventing unintended pregnancies.
B)
In
postpartum period –
i.
Insertion of IUD in immediate Postpartum period & after abortion (soon after vaginal delivery i.e. at
Labor Room) IUD can be fitted Postpartum insertion within 48 hours of delivery
is a recommended procedure with all safety. Though postpartum insertion is not
popular in India but in some countries this procedure is being accepted by the
women and community.
How the
programme can be made effective in India too? To be effective counseling of the
couple should start in antenatal visits since a woman may have difficulty
making a carefully considered decision about contraceptive use while she is in
labor pain. Further, help of a HCP who is specially trained in postpartum IUD
insertion must be available when a woman delivers which is not an easy
proposition in India. The major disadvantage of postpartum insertion is the higher expulsion rate and increased
probability of perforation of uterus. The IUD is more easily expelled after
childbirth because the uterus (womb) is frequently contracting and the cervix
(mouth of the womb) remains partly dilated. Surprisingly, expulsion rates
following postpartum IUD insertion are lowest
when the IUD is inserted within 10 minutes after the expulsion of the placenta.
Placement of IUD correctly i.e. high in the fundus is mandatory to minimize
expulsion. When a copper T IUD is inserted within 48 hours after delivery by an
experienced provider, expulsion rates at six months ranges from 6 to 15 per 100
insertions and the health care provider’s skill and experience are probably
very important to minimize of expulsion rate and other complications.
Technique of insertion
of IUC soon after childbirth
The process
of introduction of IUD is techmiquelly a bit different at this stage. One can
use a specially devised long insert for
post partum insertion. Sounding the uterus should be avoided because of the
risk of perforating the soft uterus. IUDs are usually inserted in immediate
postpartum period by hand rather than with a standard inserter. Immediate
postpartum insertion of the IUD can also be done by means of a sponge holding
forceps. However if the inserter is used at all then the arms of T-shaped IUD
should be released from the inserter once it has passed the cervical canal.
Then the open IUD can be lifted up to the fundus. The uterus may be massaged to
imitate a contraction so that wall of womb becomes relatively firm thus
preventing perforation.
The
disadvantages of immediate postpartum insertion of the IUD is its higher
expulsion rate and uterine perforation, Therefore most authorities advocate
insertion after 4-6 weeks of delivery. Insertion between the time period 48
hours to six weeks after childbirth carries an increased risk of sepsis and
perforation. Many therefore advise against inserting IUDs during this period.
During caesarean Section:
Occasionally
a woman can fitted with an IUD at the time of delivery by abdominal route. In
these settings possibly it is the Obstetricians choice rather than acceptors
decision, but when there has been prolonged labor or premature rupture of
membranes, insertion during caesarean operation should be avoided because of
the risk of infection.
Role of antibiotics in
immediate postpartum period:
There is
still debate about routine use of antibiotics after fitting an IUD. The present
consensus is not to use prophylactic antibiotics routinely in all cases.
However, in settings of both high prevalence of STIs and limited STI screening,
facility such prophylaxis may be considered or else HCP may counsel the IUD
user to watch for symptoms of PID, especially during the first month. If
symptoms appear (pain, fever, white discharge) then one can prescribe
antibiotics.
i. During lactation period without
having restoration of menstrual period: IUD can be fitted if urine for pregnancy test is negative
but this should be fitted at least six weeks after childbirth. Earlier, there
was some concern that insertion during lactation might involve a higher risk of
uterine perforation as the womb is still small and soft.
ii.
IUD insertion after abortion –
IUD can be introduced after surgical evacuation of
uterus (abortion) if there is no sepsis.
Insertion during
postabortal period
i)
When
abortion occurs/contemplated before 14 weeks of gestation -
IUDs can be safely inserted during evacuation of the
uterus (surgical abortion). Provided the pregnancy is less than 14 weeks. The
couple should be made aware that conception can occur as early as 10 days after
abortion. Therefore effective contraception is needed soon after abortion. IUDs
can safely be inserted after spontaneous or induced abortion except in women
with evidence of pelvic infections or septic abortion.
WHO studies
show moderate expulsion rates associated with IUD insertion following first
trimester abortions – ranging at two years from 5 to 9 per 100 women after
induced abortion and from 10 to 14 after spontaneous abortions.
ii) When
spontaneous abortion occurs or Medical Termination is contemplated between the
period 14 weeks to 20 weeks pregnancy. It is not customary to fit IUD after
second trimester abortion (14-20 weeks of pregnancy). Because there is 5-10 times
more chance of expulsion of the IUD is being inserted immediately after second
trimester abortion (WHO Task Force Study, 1985). So it is better to wait for 4
weeks or till the next period ensue whichever is earlier.
Safety Concerns: It is a safe contraceptive though
misperceptions about the risks associated with IUD use are well documented.
Although every contraceptive intervention has its risks, including failure and
the much greater medical risks associated with pregnancy and childbirth, the
overall safety profile of modern IUC is among the best in the contraceptive
armamentarium.
When to consult HCP; Warning symptom s & Signs while with IUD:
One
needs to call a health care provider immediately if any of the following
symptoms or abnormalities appear e.g.
1)
String
can no longer be felt, possibly the device has fallen out of womb.
2)
Something
hard is felt in her vagina or at the lower end of cervix. It means that one is
palpating the lower part of vertical arm of the device. It the device remains
at its proper place then it can neither be seem by HCP nor can be felt by the
acceptor. Therefore if device itself becomes palpable it implies that device
has come down and possibly is on the way of expulsion.
3)
Strings
seem shorter: It may imply that the device might have undergone some rotation
on long axis of womb and has coiled up in the womb. If the string seems longer
than before it may imply that device has started to descent while the device
still remaining in the womb.
4)
A
missed or a late period, a very light period, severe cramping and/or abdominal
pain which was not experienced earlier may mean pregnancy outside the womb i.e.
ectopic pregnancy.
5)
Client
considers that she has been exposed to STD.
6)
Bleeding
during intercourse or,
7)
Foul
smelling vaginal discharge (acute pelvic infection i.e. infection of upper
genital organs).
If any such situation arises then the
acceptor should consult HCP within couple of hours.
Management of possible side effects of the IUD:
The list of possible side effects associated with IUD use are:
i)
Uterine
Cramps
ii)
Menstrual
irregularities
iii)
Pelvic
infection
iv)
Spontaneous
expulsion
v)
Accidental
Pregnancy
Many
do not have any adverse effect at all and keeps fine. That is also why the IUD
called worry-free contraceptive a forgettable contraceptive. Only few have
symptoms and a few are bothered or distresed with side effects. The common
discomfort quoted by the acceptors are ‘bleeding irregularities’ and ‘pelvic
pain’. Why some women have side effects and other women escape? Firstly, health
care providers need to know that not all women are suitable for IUD. Therefore
if the acceptors are not properly selected then IUD related side effects will
be more. For instance if there is pelvic infection, or uterine abnormality then
side effects are bound to occur. If IUD is fitted inadvertently in such women.
Side effects thus can be minimized by proper selection of clients and strictly
adhering to contraindications of IUD use as framed by W.H.O. and other
international agencies. Secondly, these side effects can be further minimized
if the IUDs are fitted by an experienced and skilled nurse or doctor who has
adequate training on IUD insertion. The
cause of cramps in lower part of tummy either during menstruation
(dysmenorrhoea) or in between periods are often caused by slight malposition or
malrotation of IUD inside the uterine cavity (womb). The pain is usually
relieved by usual analgesics and NSAIDS. Persistene pelvic pain however may not
only be due to abnormal position of the IUD associated PID, but also occasionally
uterine perforation, beginning of expulsion of the IUD, or rarely ectopic
pregnancy may also be the cause pelvic pain. One has to remember that womb is a
hollow muscular organ and constantly undergoes contractions and relaxation.
During a height of continue muscles of uterus pres the device particularly if
it the device is not properly fitted. This may recurrently cause cramp in lower
part of belly and irregular bleeding. Scientists have now devise newer frames
with flexible joints in the transverse bar of ‘T’ device which allows the IUC
to repeatedly yield and accommodate the changing shape of womb with each
contraction and relaxation sadly, these devices are still not available in the
market.
IUD induced menstrual disturbances (Bleeding related problems):
Variety of
menstrual disorders which however occasionally quoted by the acceptor are as
follows. 1) Spotting between periods i.e. inter menstrual bleeding 2) heavy
periods or longer menstrual flow (menorrhagia). These menstrual aberrations
usually last for first three months after insertion of IUD and fortunately most
of these subside by three to six months time. Only in few cases HCPs (Health
Care Providers) are forced to remove the IUD if the magnitude of suffering is
considerable persistent or non relieved by drugs.
a)
Incidence
and severity of bleeding: In a normal
menstrual cycle i.e. without any IUD, the mean amount of menstrual blood loss
(MBL) was previously thought to be approximately 35 ml. With improved
techniques of extraction of blood from sanitary napkins, this amount is now
estimated to be approximately 60ml. Excessive or prolonged menstrual bleeding
(menorhagia) affects between 5% to 30% of women of reproductive age i.e.
general population not using contraceptives. It is more common among women
under the age of twenty and over the age forty years than.
The amount of blood lost in each
menstrual cycle is slightly greater in women using copper-bearing IUDs than in
nonusers. With the most commonly used IUD there is only an average increase of 20-55% in MBL which most women accept. By
contrast, with the leonorgestrel releasing IUD (Mirena IUS) which is now used
in India for last 5 years the amount of blood loss is significantly reduced,
declining to approximately 25ml/cycle.
b)
How to gaze severity of bleeding? A personal interview
and total number of napkins needed per 24 hours will often help the HCP to
assers the severity of bleeding. If a woman who is on IUD complaint of weakness
in addition to excessive bleeding then HCP can think of chronic anemia due to persistent heavy bleeding. In absence of any
other evidence of blood loss e.g. piles, worms infestation and haematemesis the
possibility of IUD induced anemia
should always be considered. It implies that menstrual bleeding is too much to
cause anemia. In these cases the HCP should insist on hemoglobin estimation. If the level is below 9gm% then he (HCP) can
request for estimation of serum ferritin
level in blood provided such laboratory facilities exists in the locality
in which the client resides. Serum ferritin is a very sensitive indicator of
tissue iron stores. Persistent menorhagia without concomitant iron
supplementation is likely to cause significant decrease in serum ferritin
levels. Low blood ferritin is an indicator of depletion of iron store in the
bone narrow as well. Therefore a conscientious HCP may occasionally request for
ferrtin estimation amongst women with menstrual bleeding disorder and levels
less than 4mg/lit should always require oral iron supplementation to prevent further
anemia.
c)
Why bleeding and pain? As said earlier most bleeding
irregularities including painful cramps occur due to inproper fitting of IUD.
If there is slight tilt or rotation of IUD inside the womb or angulation between the long axis of womb and
long axis of IUD then device will lead to repeated mild trauma in the inner
wall of womb and induce pain and menstrual bleeding. We know that muscle of
womb contracts and relaxes at definite intervals even in nonpregnant state. If
the device inside the womb is ill fitting then it will hinge the inner wall of
womb and induce pain and bleeding during height of contractions. A simili can
be drawn with small foreign body (fishbone) stuck at throat which causes pain
during each act of swallowing unless the fishbone passes down (antoadjustment)
or removed.
In addition to ill-fitting the other causes of pain and excessive bleeding
are due to – i) P.I.D. ii) at the beginning of expulsion of IUD iii) associated
PID or ectopic pregnancy (tubal pregnancy) All these may cause pelvic pain and
bleeding. Hence persistent pain or bleeding should be always investigated
properly by the experts.
d)
How to prevent bleeding: Besides selecting the
acceptor the proper selection of appropriate sized IUD and proper placement of
IUD by a skilled person are key factors to minimize bleeding related side
effects. Researchers have now been able to devise new devices which cause minimal menorrhagia (excessive menstrual
loss). These new IUDs have also succeed in reducing the likelihood of expulsion
and lowering of pregnancy rate further. It is hoped that future designs of IUD
will focus on reducing these side effects even further.
e)
How to treat pain and bleeding: For short-term relief
three types of drugs are used with varying success. These are tranexarmic acid,
NSAIDS or mefanamic acids with varying success. One can try with tranexamic
acid, 500 mg 3 times daily for three days and then 500 mg twice daily for 2 day
particulars during heavy or prolonged bleeding phases. This drug is available
as Pause 500, TX 500 etc. Alternatively, NSAID group of drugs e.g. ibuprofen
(400 mg), indomethacin (25 mg) two times daily may be tried. Mefnamic acid
tablets are increasingly used nowadays. These should be taken twice daily after meals for 5 days
and this may ameliorate heavy or prolonged bleeding. These are available as
ponstan 500 or meftal 500 etc.
Some doctors do prescribe these
nonsteroidal anti-flammatory drugs (NSAIDS) e.g. ibuprofen, mufanamic acid etc.
prophylactically i.e. from the onset of first menses after IUD insertion and
maintain such schedule for three to five consecutive days. This by decreasing
pain and bleeding certainly increase clients her confidence on IUD. NSAIDS
therefore prescribed in anticipation will yield a dividend most cases.
Occasionally these drugs will not
work and heavy or prolonged bleeding persists. If there is no reason to suspect
on underlying local i.e. gynecological cause of bleeding, there are two
options. Firstly she can continue using IUD method and in that event she should
take iron tablets and/or eat foods containing iron, to help prevent anemia.
This policy, however, is only acceptable when pain and bleding is partly
reduced by above mentioned drugs and the woman is not that distressed with pain
and bleeding. But if she shows signs of severe anemia and severity of bleeding
is unacceptable then one should remove the device and advise her to choose
another method.
Removal due to pain and bleeding is
less common among older women, multipara and in long-term users. The removal
rate depends a lot on the preinsertion counseling and support that a woman
receives and on her altitude, both familial personal, towards her trouble with
IUDs.
How does bleeding affects general
health of a woman? The effect of bleeding is almost nil in healthy women but
may lead to increased anemia already anaemic woman. Indian National Family
Health Survey-3 (study period 2005-’06) has unearthed the fact that 39% of
Indian women are mildly anaemic haemoglobin level <10 to 10.9 gm/d and 16%
are moderately anaemic. There is of women by 4% the
period 1098-99 to 2004-05. <70-9.9 gm (d) and 2% are severely, anaemic (H
level 7 g/d).
Anaemic usually passes off within a
month or two. The client should be reassured about it. In fact, no aggressive
treatment is warranted.
f)
Removal Rate: The single most common side effect leading to
IUD discontinuation is disturbance in menstrual bleeding. The experience of
excess bleeding is often accompanied by pain also. These two side effects
either alone or in combination are not too uncommon. Inspite of adequate
counseling and medical treatment in 2-10% of cases IUD have to be removed for
persistent menstrual bleeding and pelvic pain. Providers should always offer
clients the choice of switching method if they are not satisfied or if their
needs or preferences have changed.
g)
How women and society view about normal menstruation?: Women’s
attitudes about menstruation are shaped not only by experience but also by
beliefs about the social and cultural meaning of menstruation and what is
acceptable monthly bleeding, taboos, and behavioral restrictions. Although not
all belifs are reflected in practice, in many places cultural and religious
beliefs prevent menstruating wome from participating in worship, sex, domestic
works and many social activities. In some societies menstruating women should
not visit places of worship. In some conservative societies menstruating women
are not allowed to perform event heir domestic chores such as cooking and
washing clothes. Sexual intercourse should be avoided during monthly bleeding.
In contrast, only about half of women in the united kingdom, the only developed
country in the study, believed sex should be avoided during monthly bleeding.
Even among women who thought that it was acceptable, however, many did not have
sex then as a matter of personal choice.
h)
How a woman react to menorrhagia?: If is retreated that these bleeding changes are rarely
harmful, and they do not signify underlying or impending illness. But a woman
reacts to bleeding changes and to what extent one tolerates depend on many
factors, such as on the type and severity of bleeding changes and how severe it
is, or whether it interferes with her daily activities or personal
relationship, and also traditional beliefs or restrictions surrounding bleeding
days. These changes however are not signs that something is wrong with her
health. It is not the bleeding change itself, but rather how the woman feels
about it and interprets it that will determine how she reacts. It should be stressed
that these bleeding changes are normal and not signs of serious illness.
i)
Do other contraceptives cause such bleeding?: Bleeding
and spotting at unexpected times are also common among women using oral
contraceptives (20% of cases particularly during the first three months). The
good news is that this drop to about 10% of cycles during the next three
months, and to approximately 5% of cycles during the last six months of a
12-month period.
In summary, the following information
may help the clients.
a) Spotting or light bleeding b)
Heavier or longer menstrual
between menstrual
periods. bleeding than normal
(not amounting to
anaemia) menstrual periods.
(The amount
blood loss is such that there is a
threat for becoming anaemic)
|
a)
HCP should
counsel that spotting or light bleeding is common during the first 3-6 months
of copper-bearing IUD use. It is not harmful and usually decreases over time.
|
a)
The following
treatment should be offered during the days of menstrual bleeding.
Non-steroidal
anti-flammatory drugs (NSAIDS) or Tranexamic acid haemostatic agent). Aspirin should not be used.
|
|
b)
If she desires
treatment, a short course of non-steroidal anti-flammatory drugs (NSAIDS) may
be prescribed during the days of bleeding.
|
b)
If bleeding
continues to be very heavy or inspite of blood coagulating agents and there
are clinical signs of anaemia, or if she finds the bleeding unacceptable,
early removal of the IUD is the best option.
|
|
c)
If women is
bothered with persistent spotting and bleeding then one should exclude other
gynecologic problem. If a gynecologic problem is identified, it should be
treated by a specialist. There is no need to removel IUD.
|
|
|
d)
If no
gynaecologic diseae can be held responsible for bleeding, and she finds the
bleeding unacceptable removal of the IUD should be done and one should help
her to choose another method.
|
|
(Courtsey: World Health Organisation)
3. Pelvic infection (PID-Pelvic
inflammatory disease):
Female
genital organs are arbitrarily divided into two compartments e.g. lower genital
tract and upper genital tract comprises of external genitalia (vulva) and birth
canal (Vagina). The upper genital tract comprises of womb (uterus and its mouth
i.e. cervix), fallopian tubes, with i.e. egg transport tube which carries eggs
from egg relasing organ (ovaries) to womb.
PID is the
infection of upper genital organs. The abbreviation ‘P.I.D.’ stands for ‘Plevic
Inflammetory Disease’. There are many organisms responsible for PID. Some
organism responsible for sexually transmitted diseases can also cause PID. Poor
hygiene, under-nutrition, pelvic tuberculosis and above all repeated induced
abortions can initiate PID. Abortion can procedure even if carried by experts
in an clean environment can result PID. So surgical abortion is not cent
percent safe and should be avoided as far as possible. The long term ill
effects of PID are chonic pelvic pain. low backache. Infertility or pregnancy
in fallopian tube, i.e. ectopic pregnancy. The very anatomy of fallopian tube
and crypts in cervix are such that any infection in these areas are difficult
to cure by drugs surgery permanent.
Coming to the
question of whether IUD inserted inside the womb will invite PID or not was a
debatable issue. Opinion of scientists still vary people have different views.
In the decades of seventies and eighties both reproductive scientists as well
as acceptors of IUD firmly believed that the risk of genital infection will
remain high during the entire period of IUD wearing. In the 1992 international
conference on IUD critically analyzed the review published by WHO which was
meta analysis (summary of many studies analyzed together) involving nearly 22,
908 IUD users (using a total of 10 different IUD types) around the world.
Result of that reviend supports the relative safety of IUD use so far as PID is
concerned. All the researchers unanimously and firmly concluded that copper
IUDs do not promote PID.
Metaanalysis
also point that PID rates were highest among young IUD users in certain geographic
regions. PID rates were high among IUD users in Africa and lowest in China were
bilateral monogamy is the usual rule.
The observers
who were in charge of analyzing such data finally concluded that much of the IUD associated PID occurs in women who
are at higher risk of STD infection, i.e. primarily women with more than one
sexual partner or whose partner has other sexual partner.
To summarise on the issue of IUD
induced PID’ it may be infersed that a) overall, the rate of PID among IUD
users was very low (1.6 cases per 1,000 woman years of use) b) the rate of PID
was highest during the first twenty days after insertion (9.7 cases per 1,000
insertion) and remains low and stable thereafter (0.5 to 1.4 cases per 1,000
woman years of use) c) some physicians employ preventive antibiotics before
inserting the IUD, but the meta analysis did not find that this was helpful. d)
twenty days after insertion of IUD the risk of PID remain very low, even among
users who had an IUD in place for eight years or more. In the event the woman
develops evidence of genital infection (P.I.D.) while on IUD it is not
necessary to remove IUD. Instead potent antibiotics should be prescribed in
consultation with HCP. Removal of the device during the infection does not
ameliorate her symptoms or modify the course of PID in any way. IUD, however
can be removed if the client so demands or if evidences of infection do not
subside inspite of adequated treatment for reasonable period of time.
Spontaneous expulsion of IUD and management of missing thread:
The
management of such complications is detailed below and a knowledgeable acceptor
can react readily if such mishap ensues.
An
estimated 2% to 8% of IUDs are expelled from the uterus within the first year
of use. After insertion of IUD there is a natural tendency of uterine
contractions to push the device (a foreign body) downwards, causing partial or
complete expulsion though the T-shaped frame itself and the irregularity
present in the T-arm prevent downward displacement of IUD.
Expulsion
is most likely to occur during the first three months after insertion. Several
factors influence the chances of expulsion. Young mulliparous women have higher
expulsion rates for all devices than parous women. After the first child there
is a negligible effect of increasing parity on the expulsion rate. However, IUD
expulsion rates seem to decline in a fairly linear fashion with increasing age.
Women who had painful menstruation or abnormally large menstrual flow are more
prone to expel copper-T-IUDs. The main increase in expulsion rate occurs when
IUDs are inserted during the menstrual flow and is probably linked with extra
myometrial activity (muscles of womb) at that time due to presence of excessive
prostaglandins (a chemical agent).
What is the advice for acceptors?
All acceptor
should palpate the thread after cessation of each menstrual period. If client
is unable to feel the string herself she should seek help of HCP. Till then she
should use some other contraceptives Similarity if the client can feels the
plastic part of device it means that device has slipped down and then also she
should visit HCP. Thus if the client can feel the lower part of frame in the
cervical canal (neck of the womb to be more precise) then possibility of threatened expulsion is suspected, and
she should immediately consult HCP. HCP too if cannot feel or visualize the
string then the provider should consider three possibilities.
a)
The
IUD has fallen out of body without the knowledge of the acceptor. This may
happen during menstruation, defecation or urination.
b)
The
IUD has changed its position inside the womb (coiling up) and in the process it
has drawn string upwards inside the womb.
c)
The
least possible cause is its perforation inside tummy (very rare).
What HCP will do in such situation?
In
this situation, after pelvic examination has been performed and the possibility
of pregnancy excluded by urine test an ultrasonography
should be done which will confirm or refute the position of IUD inside the
womb. Ultrasonography can enrich us with three types of report e.g. a) The
device is still inside the womb (coiling of IUD). In such situation the device
should be removed by a minor operation e.g. hysteroscopy or more D & C
depending on the expertise of the surgeon. A fresh device may be inserted if
the couple commonly dicers. b) Device but has perforated the uterus and is in
tummy. If sonography confirms that the device has gone inside the belly then it
should be removed by laparoscopy. c) More commonly the sonography will reveal that
there is no IUD either inside the womb or inside tummy. Then it may be inferred
that device fallen out of the body. In such case another device may be fitted
provided woman agrees else couple can opt for some other contraceptive method
of their choice.
In
all such cases where string can’t be palpated a postcoital contraceptive should
be considered if she has recent sexual activity and a backup contraceptive
should be adopted till another contraceptive selected.
Limitations as a contraceptive:
1)
Side effects in some women in the form of pelvic
cramps and irregular bleeding.
2)
Spontaneous expulsion of IUD: IUD
may be expelled spontaneously from the womb without the knowledge of the woman
in up to 10% of women. This will be evidenced by inability of the woman to feel
the string of IUD in the upper part of birth canal. The expulsion rate of IUD
during first year of use is high and it is rare to have IUD expelled after
first year of use.
3)
Invites infection to genital tract: There
was a longstanding debate whether presence of IUD inside the womb invites
infection to cause P.I.D. (pelvic inflammatory diseases). Now different
international studies have proved that in monogamous relationship IUD does not promote P.I.D. Still many
skeptic scientists do not recommend IUD insertion in nulliparous women in care
there is IUD induced infection which may lead to infertility in later life and
according to them IUD is not a good choice for nulliparous women (category 2
risk). But many unmarried or nullparous married women have been fitted with IUD
and results are encouraging. We will have to wait to see whether IUD can still
be used in polygamous women and nulliparous women but certainly the old belief
that IUD incucing PID is fast fading.
4)
Discomfort during fitting: Insertion
of IUD requires a minor medical procedure which may be somewhat uncomfortable
particularly who are apprehensive.
5)
No preventive action on STI: Contraceptives
are primarily viewed as method of pregnancy prevention rather than STI
prevention. Most women especially those who are married or in stable
relationships choose methods to prevent pregnancy rather than to prevent STI.
As IUD does not offer STI protection hence women should use her own judgement
regarding necessity of condom use in addition to IUD in their married life. She
can use barrier method in and for many women suggesting condom use is difficult
since condoms are often associated with commercial sex rather than marital sex.
6)
Stoppage of method necessitates
medical help: Unlike barrier methods or oral pills client
cannot stop using IUD of her own. The woman should never try to pull the string
herself. She has to go to a clinic for removal of IUC.
7)
Compared
to combined oral pills there is slightly increased
risk of ectopic pregnancy i.e. pregnancy occurring is fallopian tubes, but
this risk is less than women not using any contraceptive whatsoever.
8)
Rarely
perforation of uterus may follow and device can go inside to the tummy (very
rare indeed).
9)
Misplacent of IUD: An
IUD can descent while still remaining inside the womb and thus occasional
failure i.e. accidental pregnancy can follow. In fact contraceptive failure may
be due to expulsion, perforation, descent or coiling up of the device inside
the womb.
Risk stratification of women as per WHO guidelines:
Women
with some associated gynecological or medical diseases face some risk if IUD is
fitted. The anticipated risks or dangers are graded as 1,2,3 & 4. Earlier
people used to categorize the risk of contraceptive use as obsolete
contraindication and relative contraindications. Nowadays category risk 1
implies no risk and category 2 risk means slight risk (relative
contraindication). Category 4 means absolute contraindication and category 3
implies it is better to avoid the choiced contraceptive in that particular
diseases.
WHO risk categorization of IUD use is as follows:
A)
Category 1 risk: The
existing medical or gynecological disease does not cause any harm to client
neither it intensify IUC related side effects.
B)
Category
2 risk:
a)
Age
menarche to women.
b)
Endometriosis
c)
Menorrhagia
d)
History
of previous pelvic infectious diseases without subsequent pregnancy and
assuring that there is no current risk factor for STD.
e)
Vaginitis
including trichomonal vaginitis and bacterial vaginosis
f)
Thalassaemia
& iron deficiency anemia
g)
Complicated
valvular diseases of heart
h)
Soon
after second trimester abortion.
Uterine pregnancy:
A.
Causes of pregnancy:
a)
This
unfortunate event usually follows when the device
has fallen off the body without the knowledge of the acceptor.
b)
Pregnancy
may also occur if the device is coiled up
inside the womb i.e. upward displacent of the device but the device still
remaining inside the womb. HCP should always remember that to have desired
contraceptive effect the IUD should be so located that it almost touches the
top part of womb. This area is medically called fundus of uterus. If the device
is coiled up inside the womb then copper ions will be released low down in the
womb and contraceptive efficacy with fall.
c)
If
device has descended downward i.e. in
the lowermost part of womb thereby vertical limb of the device lying in the
cervical canal.
B.
How to minimize accidental pregnancy:
As mentioned earlier spontaneous expulsion of IUD or malposition of the
IUD can often be minimised if IUD is inserted by a HCP who has adequate
training and skill in IUD insertion. Correct high placement of IUD is a prerequisite for proper achieving near 100%
contraceptive action. But the author has witnessed about six dozen of such
cases where the device which was inserted by a skilled doctor has descended
down still remaining in the womb. This is possibly unavoidable and happens due
to contractions of uterus. Normal uttering contraception’s sometimes succeed in
pushing the device down particularly if the uterus is relatively large in size.
A six monthly ultrasonography may detect the correct position of IUC in womb
and can alert the HCP & client that the device has started falling from its
original location. The other ill-effect of decent of IUD is that if the deice
comes down then copper ions released will be well below fundus of uterus. This
will be unable to exert desired contraceptive effect. The process of descent of
IUD from womb to final expulsion can be associated with cramping increased
vaginal discharge, or uterine bleeding. However, in some cases, the only
premonitory symptom is lengthening of the IUD string thus the golden rule is to
palpate and search not only for strings but also to search or hard any plastic
mans in the neck of the womb i.e. opening of the womb (external os).
C. Incidence of accidental
pregnancy:
Fortunately, the annual incidence of accidental pregnancy decreases
steadily after the first year of IUD use. The cumulative pregnancy rate after
seven years of use of the copper T380A IUD (most common brand used in India) is
only 1.6%.
D. Complication of pregnancy
while IUD still remaining inside womb:
If she is pregnant with IUD still inside then there will be an increases
risk of spontaneous abortion. If the
IUD is not removed then the incidence of spontaneous abortion which is
approximately 55%, or roughly three times greater than would occur in
pregnancies without an IUD. More than half of the spontaneous abortions in IUD
users occur in the second trimester. However, if the IUD is removed right after
conception than the risk of abortion is close to average abortion rate (about
20%). For some reason or other the gestational period between 14-24 weeks is
dangerous (if the IUD is not removed) because severe infection (sepsis) may
occur. The genital sepsis can be fatal
and hence once pregnancy is diagnosed, IUD should always be removed.
E. Client wishes to continue
pregnancy - What to do?
If a woman using the IUD becomes pregnant and wishes to continue the
pregnancy then IUD should be removed at the earliest to avoid increased risk of
spontaneous abortion. These will also obviate the increased risk of septic abortion in the second trimester
and increased risk of premature delivery.
There is no evidence that the IUD in a pregnant woman increases the risk for
birth defects in the foetos.
F. The client does not wish to
continue pregnancy:
She should be advised to undergo surgical termination of pregnancy
preceded by removal IUD. Medical
abortion i.e. abortion by drugs is not recommended while IUD is still inside
the womb. However, abortion by drugs can be carried out after removal of
the device. The following procedure should be adopted if a woman using IUC is
having delay in starting period. Firstly she should palpate for strings.
Secondly, urine for pregnancy test is to be contemplated. If the urine test is
negative she can repeat the test after ten days. If this test is also negative
she can take tablet Orgamed (10), one tablet for ten days which will help
menstrual bleeding and allay her anxieties. This natural delay in period is
most commonly due to breastfeeding. If urine test is positive then one should
exclude possibility of ectopic pregnancy i.e. pregnancy occuing outside womb.
This can be done by serial blood testing for βhCG hormone and ultrasonography.
In addition gynecologist’s advice is a must.
The
concerned HCP should alert the acceptor that if the device is not removed as
soon as pregnancy is diagnosed then she is at risk of second trimester miscarriage, pre-term delivery and above
all severe infection of womb if the
IUD is left in place IUD removal is mandatory and the removal of the IUD
reduces these risks, although the procedure itself entails a small risk of
miscarriage. After removal of IUD she can continue the pregnancy if she so
wishes but there will be always some risk of miscarriage, preterm delivery. If
she opts to continue pregnancy she should be advised to seek medical care
promptly if she has heavy bleeding, cramping, pain, abnormal vaginal discharge
or fever. If she does not want to continue the pregnancy, surgical termination
of pregnancy may be contemplated along with removal of the device.
Ectopic Pregnancy (Pregnancy occurring outside the womb i.e. in the egg-transport tube).
Any
pregnancy in an IUD user, inside or outside womb is uncommon and thus IUD users are 50% less likely to have an
ectopic pregnancy when compared with women using no contraception. It is
well known that infection of fallopian tube (P.I.D.) can favor ectopic
pregnancy at a later date. Earlier, medical fraternity used to believe that IUD
promotes pelvic sepsis including infection of fallopian tubes. HCP many believe
that IUD may promote ectopic pregnancy at a greater rate than usual population.
But that is not true. It has been proved now that IUD does not provoke pelvic
infection if cases are properly selected (clients without risk of STD). Sadly,
the bad reputation of IUDs regarding increased incidences of PID and increased
rate of ectopic pregnancy (EP) still prevails not only in the minds of common
people, but also amongst doctors.
The
rate of ectopic pregnancy in the general population vary depending on
sociocultural and sexual behavior of the men and women of the locality. The
estimated ectopic pregnancy rate among sexually active women using no method of
contraception has been estimated to be between 3.25 and 8.0 per 1000 woman
years. Contrary to popular belief the incidence of ectopic pregnancy among IUD
users is between 0.125 and 4.0 per 1,000 women years of IUD use.
If
we consider the ratio of ectopic pregnancies, to total accidental pregnancies
while still wearing copper IUDs it is seen that rate of EP is 39 per 1000 total
pregnancies. This is almost similar to the ratio of 43 per 1000 pregnancies
while not on contraceptives. From this stand point it may be inferred that if a
woman becomes pregnant with IUD in place, her risk of ectopic pregnancy is
increased compared with the overall population of pregnant women. In fact,
protection against all tubes of pregnancies provided by both Tcu-380A is so
great that WHO has put these devices as category 1 (i.e. safe to use) even in women with previous ectopic
pregnancies.
Though
the incidence of ectopic is very low still it will be prudent to warn the women
using IUDs about the features of ectopic pregnancy. They should be informed
about common symptoms of EP e.g. abdominal pain, ‘dark and scanty’ or ‘inter
menstrual bleeding’ along with the usual signs of pregnancy. The women
concerned should visit HCP urgently if these symptoms appear. Another note of
caution. If an IUD user conceives, health care provider should always look for
ectopic pregnancy by sonography and serial blood tests for beta-hCG hormone.
In
summary it may be said that IUD users are statistically less protected against
ectopic pregnancy than users of other contraceptive methods. One should
remember that IUD does not prevent ovulation and possibly does not impede
fertilization. IUD prevents nidation by primarily altering the inner
environment of womb. Thus IUDs protect intrauterine pregnancy more effectively
than extra uterine pregnancies.
Newer Copper IUDs:
Researchers
continue to develop and test new IUDs that may reduce expulsion rates and other
side effects. Among the devices being that has become successful is CU-SAFE
300. It is smaller, lightweight, and flexible T-shaped copper IUD which can be
inserted without a plunger and is designed to move towards the uterine fundus
(the top of the uterus) when the uterus contracts. Additionally another new
device is getting fast popularity i.e. frameless IUD consisting of six copper
sleeves on a surgical nylon thread. It is also Flexi Gard 330, or Cu Fix PP
330. The thread is knotted at one end, which is anchored in the muscle of the
fundus. In clnical trials the device has proved to be highly effective and
comfortable to use. A Copper bearing IUD with a T-Shaped frame, called the
Sof-T is becoming popular at smiliserlad. In thus new device. The tip of each
end of the arm consists of a soft ball, designed to prevent perforation and to
block the openings to the fallopian tubes in order to prevent sperm from
entering.
The
very purpose of these new devices is to reduce pain and irregular bleeding
associated with in the existing copper beeaing IUDs including the most popular
type i.e. T-Cu-380A. Earlier the plastic frame where of different shapes e.g.
coil, ‘s’ shaped, circular, triangular or elliptical. Now the only shape recommended
is ‘T’ shaped because the cavity of womb is like ‘T’ which fits well with
geometric of uterus and adaptation inside the womb is satisfactory if the
plastic is of some other type then the frame will hinge the inner wall of womb
and cause uterine camps and possibly bleeding.
Additionally the very plastic used is
now made up of more flexible material. We are aware of the fact that womb
contracts and relaxes spontaneously at varying intervals without the knowledge
of a woman. If a ‘rigid’ plastic frame is used then it will not yield or bend
to accommodate the shape of the contracted womb. So a rigid plastic frame is
bovend to cause cramps and bleeding irregularities. However new copper IUDs
discussed below are not approved for use in all countries. Till date the
developers and manufactures report fewer expulsions, higher continuation rates,
lower failure rates and easy insertion-removal as main advantages of all these
new copper IUDs.
Chapter XII ABC BOOK (Contraceptives for sick women)
Role of POP in women with high blood pressure:
Women
with high blood pressure are prone to have ‘heart attack’ or ‘cerebral stroke’
i.e. bleeding from arteries inside brain matter or clotting of blood in venis
inside the brain substance. It is said that hormonal contraceptives by changing
coagulation system in the body and by altering fat metabolism adversely promote
these fetal accidents. Thus one should
try to avoid hormonal contraceptives in hypertensive women. But it is
equally true that the hormonal contraceptive and IUD (Intrauterine Device) are
the two most reliable temporary methods of contraception. The existing other
temporary methods are not so much effective. Therefore, if one options for
effective temporary method the option will be either IUD or hormonal methods.
But many Indian women do suffer from variety of gynecological diseases where
use of IUD is contraindicated. In them one has no other option but toprescribe
hormonal contraceptives even if her blood pressure is slightly raised. Thus one
has to make a balance between efficacy and risk of contraceptive use in women
with high blood pressure.
POP,
though a hormonal contraceptive but the hormone is used in very low dose. So
POP is reasonably safe to prescribe in women with mild to moderate hypertension
even if she is on antihypertensive (i.e. drugs to check high blood pressure).
To initiate POP the upper level of blood pressure (systolic) should be ideally
less than 159 mm of mercury and the lower limit of blood pressure (i.e.
diastolic) should be below 99 mm o mercury. These readings may be with or
without blood pressure reducing drugs. But POP is not usually prescribed in
women if blood pressure is above 160 systolic and or above 100 mm of mercury
diastolic (WHO category 2 women for POP usage). That is only in special
circumstances particularly when more
appropriate methods are not available acceptable to the couple then only
POP may be used in such women. The HCP need to assess the severity of her
circulatory system and whether the woman will come regularly for follow up.
Conceivably, these women mandate frequent three monthly follow up of POP is at
all used.
It
may be recalled that traditional COCs are very risky (category 3) in women with
such high blood pressure. Copper bearing IUDs are the safest the temporary
contraceptive method for hypertensives and diabetics too. The other options are
POP Mirena IUS (Hormonal IUD). Though women with slight elevation of blood
pressure may use hormonal IUS but if hypertensive is severe (blood pressure
> 160/100) then she should not use LNG-IUS.
RISK SATISFACTION OF
HYPERSENSIVE WOMEN
|
|
Mild hypertension
BP < 140-159/90-99
|
Severe hypertensive
(> 160/100)
|
|
|
Barrier
|
1
|
1
|
|
|
LAM
|
1
|
1
|
|
|
COC
|
3
|
4
|
|
|
POP
|
1
|
2
|
|
|
Quarterly
Shots
|
2
|
3
|
|
|
Implants
(Implanon)
|
1
|
2
|
|
|
Combined
monthly Injection
|
3
|
4
|
|
|
Copper
containing IUD
|
1
|
1
|
|
|
Hormone
releasing IUS
|
1
|
2
|
|
History high BP in pregnancy but
current level is normal – COC is category 2 risk but POP and Quarterly Shot may
be used.
Safety POP in Diabetes: (high blood sugar):
In
recent times prevalence of diabetes and high blood pressure has gone up in
India. What about use of POP in diabetics? Is POP safe? The following is the
guideline.
1)
Those
who had temporary rise of blood sugar during pregnancy (gestational diabetes
mellitus) they can safely use POP. Alternatively, they can also use COC with no
added risk (zero risk or category I women for COC usage). In fact all methods
are safe for women who had such temporary rise of blood sugar.
2)
Those
with established diabetes but sugar is within control, they can also use POP or
COC provided there is already no change in the blood vessels as evidenced by
eye (retinal) examination. Even those who are using insulin can use COC or POP
provided diabetes is well controlled and there is no associated vascular
disease. However, these two hormonal contraceptives i.e. POP and COC are
contraindicated if diabetes is not well controlled.
3)
Those
diabetics who had already some retinal changes (vascular changes in the eye
ball as evidenced by simple clinical examination by ophthalmoscope, Kidney
changes or nerve changes they too can use POP (category 2 risk). COC will be
more risky in such women (category 3 risk). In fact all methods except copper
bearing IUDs are category 2 risk for women with established diabetes mellitus.
It is needless to mention that barrier contraceptive and natural family
planning methods fertility Awareness method) are safe options but efficacy of
these are limited. Use of spermicides in uncontrolled diabetics may invite
severe pelvic infection and thus not recommended.
POP in HIV and contraceptive choices for HIV Women:
Women
account for nearly half of the estimated 40million cases of HIV infection
worldwide. In 2006 on estimated 17.7 million women ages 15 and older, or about
13 in every 1,000 such women, were infected-approximately one million more than
in 2004.
Like
all other women, women with HIV have the right to make their own decisions
about their reproduction and sexual health.
Women
with HIV face many decisions about living with HIV. Decisions about sex and
childbearing can be among the most important. She may also need to ask her
partner if he knows his HIV status and, if not, encourage him to seek HIV
testing.
Preventing
unwanted pregnancy is a key element
in the four-element strategy for preventing mother-to-child transmission of
HIV. As indentified by the UN in the Glion Call to Action on Family Planning
and HIV/AIDS in Women and Children, the four elements respond to health care
providers’ four opportunities to reduce mother-to-child transmission. The Glion
Call to Action states that all four elements are essential for meeting the UN
goal of halving the proportion of infants infected with HIV by 2010.
All hormonal methods appear to be safe for
women with HIV. Theoretically, certain antiretroviral (ARV) medications could
reduce the effectiveness of low-dose hormonal methods, but
CHAPTER –
IV(Final)
Intrauterine
Devices: Intrauterine contraceptives:
(Contraceptive Coil)
INDEX
Basics of IUDs – P, Type of IUD – P, Information on string of IUD – P,
Brand names & Life span – P, Mode of Action – P, How soon become effective
– P, Contraceptive efficacy – P, Users satisfaction & Continuation Rate –
P, Advantages as contraceptive – P, Side effect and their management – P,
Disadvantages as contraceptive – P, Candidacy for IUDs – P, Who criteria &
Checklist – P, IUD & Timing of insertion – P, Insertion Procedure – P,
Follow up – P, When to remove (Indications for removal) – P, Procedure of
removal – P, Switching to some other method – P, Return of fertility – P,
Complications, Health Risks & warring – P, Skill of HCP – P, Pill or IUD
which one to choose – P, LNG IUS or copper beaing IUD – P, Conclusion – P,
Further Reading – P, Webs – P.
The basics of IUDs:
An IUD (also
called IUC) is a small ‘T-shaped’ flexible plastic device that is inserted
inside the womb (uterus) through birth canal to avert pregnancy (Fig-1). It is
the world’s most widely used reversible birth control method for women. The
letters ‘IUD’ stands for “Intrauterine Device” and IUC is for intrauterine contraceptives. Both
abbreviations are for the same device. The ‘contraceptive coil’ or ‘loops’ are
just other names for the same contraceptive. Earlier it was used to be called
as IUCD i.e. intrauterine contraceptive device. Globally the present
abbreviation is IUD and only in some countries it is called IUC.
IUD is an
easy, convenient, highly effective form of contraception that does not
interfere with sexual spontaneity. Once
introduced the IUD is immediately effective. It can also be used as
emergency contraceptive i.e. as after sex conceptive if the IUD is
fitted within seven days of unprotected sex. The sooner the device is fitted
after unprotected sex more will be the contraceptive efficacy.
Not all IUDs
are alike. There are several types, and they come in different sizes and
varying shapes. Like other drugs and devices there is long history of its
evolution and hundreds of IUD have been tried in last two centuries. Readers
will be surprised to know that the idea of putting some device inside the womb
to prevent conception initiated with contraception camels. Camels frequently
undergo long journey in the desert. To avoid pregnancy during this long voyage
some pebbles (stone like material) used to be inserted in the womb of camel.
Thus the camels did not fall sick in the voyage.
Basically
there are two types of IUDs. One is copper
impregnated IUDs which when fitted inside the womb release copper ions and
other one is progesterone hormone
containing IUDs which releases in sick the womb. It is the released copper
or progesterone which effect contraception though plastic frame itself has some
contraceptive effect. Copper bearing IUDs have proven the test of time and most
popular form of IUD. In fact, there is a museum which exhibits over 300 IUD
designed over two centuries collected from different countries.
Copper
containing IUDs are the most inexpensive long-term reversible method of
contraception. It can be removed at any time and fertility resumes within
couple of months. The IUD requires no daily attention and this is the distinct
advantage over contraceptive pills, or condom. The only responsibility of the
acceptor is to confirm the placement of IUD after each menstrual period by
feeling the thread of IUD which hangs in the upper part of birth canal. The
thread is tied to the lowermost part of the device.
Like other
contraceptives it has its own limitations and disadvantages. For instance, IUDs
must be inserted and removed by a health care professional. It should never be removed by the client
even if the thread is easily palpable. Occasionally the device causes menstrual
irregularities and cramps in the lower part of belly (uterine cramps). Rarely
there can be spontaneous expulsion of the device through birth canal
particularly during excessive straining at defecation.
Principal Types of IUDs:
Classification of Medicated
IUDs: All modern IUD
contain some active sustances either in the form of metal (e.g. copper) contain
synthetic progesterone hormones. So modern IUDs are called medicated IUDs. Unmedicated i.e. only plastic devices are less
effective. Though these were once popular in the decade sixties and seventies
are no longer used nowadays.
Classification of Medicated IUDs:
Medicated
IUDs are of two types
a) Copper bearing IUDs and b) Hormone releasing IUDs. First group and most
widely used is copper bearing IUDs
has a band of copper (either in the form of wire or sleeve) worn around the
plastic device. This type of copper bearing device can be kept inside the womb
for 3-14 years depending upon the copper content. The most popular copper
containing IUD is T-cu-380A which
when fitted is effective for fourteen years. In U.K. & U.S.A. it is sold
under the brand name of ‘PARAGARD’.
The second group is hormone containing
IUDs which contains a special hormonal reservoirs from which small amount
of female hormone called ‘progesterone’
is released daily inside the womb and effect contraception.
This second
group of IUDs again is of two types depending upon the type of progesterone
used. If ‘pure progesterone’ is used then it has to be replaced annually. Such
device is available in the market under the trade name Progestasert but for varying reasons it is no longer used and it
was never been available in Indian market.
The other
type of hormone containing IUD is impregnated with ‘levonorgestrel’ type of progesterone. This relatively newer type of
hormonal IUD is gaining popularity at a very fast rate because it has the
ability to ameliorate variety of gynecological diseases in addition to
contraceptive effect. Fortunately it has become available in India since 2002
(under the brand name Mirena IUS Fig.-2). Scientists often call it ‘LNG-IUS’ or
LNG-20. The word LNG- stands for ‘levonongestrel intrauterine system’. In
this book the word ‘LNG-IUS’ will be used to mean this type of hormone
releasing IUD. The contraceptive efficacy of this IUS lasts for five years.
Many other
IUDs which were used in the twentieth century are no longer used. These are
safe coils, Lippes loop, Dalcon Shield, Cu-7. The modern copper IUDs however
are safe, effective and inexpensive method of achieving reversible
contraception in properly selected women.
Most copper
medicated IUDs have an abbreviation depending on the design of the frame and
exposed surface area of copper wire. For instance the most commonly used copper
containing device is abbreviated as T-Cu-380A which means the shape of the
device is ‘T’, and the exposed copper wire winded around the device is 380
sq.mm. In fact this copper wire is winded both in vertical limb as well as on
the collar i.e. transverse bar of the plastic device.
Remarks on the string of IUD:
As mentioned
earlier the only commitment of the client after the IUD is fitted is to cheek
the presence in the upper part of vagina at monthly intervals. Thus it is
worthy to know few relevant points pertaining to the string attached to IUD.
Both copper
medicated and hormone containing IUDs have one or two ‘filaments’ or ‘strings’ –
that is threaded through a hole in the bottom of the vertical arm of the device
which is shaped as T (sig. Fig.-3). The strings are tied in the device with a
knot and strings hang through the lower opening of the cervix into the upper
birth canal. The string is monofilament i.e. a single strand of strong plastic.
Contrary to popular belief, this thread which hangs in the birth canal does not
absorb fluid from birth canal neither transmits bacteria up into the womb. The
partner do not feel the thread during lovemaking process neither the male organ
is hurt by the thread.
The string
has two purposes. It is primarily meant for easy removal of the device with the
help of an instrument called ‘artery forceps’. The string also gives an
opportunity to the woman clinician to know if the IUD is still in the correct
position i.e. inside the womb. As said earlier, the women or her husband should
periodically check (once a month is sufficient) its presence by touching the
string. It is best palpated in squatting position or else woman can put one foot
on a low tool and then insert her index and middle fingers in the birth canal.
It should be searched more in backwards than upward direction. Usually, the
thread is readily palpable. If not, then one can put her fingers up in the
birth canals. When she will be able to feel cervix which feel like tip of nose
with a small hole i.e. depression at centre. Some amount of mucus is easily
felt at this part and it is in this portion the string should be searched.
If the string
seems to shorten or lengthen, the IUD it may mean that have moved up inside
then womb or has come down. This mandates an ultrasonography (imaging the womb) to verify correct location of IUD
in relation to longstudinel axis of womb (uterus).
If the string
can’t be located at all it may mean that IUD has expelled spontaneously
possibly without the knowledge of the acceptor. On very rare occasion device
may have perforated the womb and travelled to tummy (abdomen). In summary the
purpose of putting a sting in IUD is as follows –
d)
It
satisfies the client that the IUD has not fallen off the body.
e)
It
helps in easy removal of IUD.
f)
If
there is there is lengthening or shortening of thread then it implies that IUD
has either come down from womb or has coiled up in the womb.
Brand Names:
A) Copper bearing IUDS:
2)
‘Multiload cu 250 (ML-Cu-250) and
Multiload Cu-375 (ML-Cu-375): The intrauterine life
span of such IUDs is 3 and 5 years respectively. The cost such IUD in Indian
market.
iii)Multiload IUDs - Multiload IUDs have
curved flexible arms with spurs. These spurs seek anchorage to fundus, thus
reducing expulsion rate. Copper wire on the stem is worn around vertical limb
of T and two popular designs are with 250 mm2 and 375 mm2
surface area of copper. Multiload 250 has lesser side effects. While Multiload
375 is as effective as Tcu-380A.
iv) T Cu 380A – Tcu-380A has solid
copper sleeves on transverse arm and coil of copper wire around the stem.
This is a highly effective copper device with efficacy as high as 99%. By
adding silver to this (TCu-380 Ag), efficacy has further improved with a
failure rate as low as 0.7%. This is available abroad under the brand name of Paragard or T-safe-Cu 380A. The name paragard was used as its use was initially
restricted to porous women only. This device was approved by FDA (Food and Drug
Authority of US) in the year 1984. In India it is sold in open market under the
brand name of “NUGUARD 380A” & T-Cu-380A is the other name distributed by
Govt. of India free of cost through all Govt. hospitals.
Globally two types of
Copper IUDs e.g. T-Cu-380A and ML-Cu-375 are the most commonly used
copper medicated IUDs which is there are about dozen of other copper bearing
IUDs still popular in different parts of the globe. These are Cu-7, T-Cu 200,
T-Cu 220C, T-Cu 220B, Cu Nova T, T-Cu 200C. These are not popular in India and
neither they are readily available in all the provinces of India.
B) Hormone bearing IUDs:
3)
IUDs impregnated with progesterone
hormone: ‘Progestasert’ is the brand name and these
have life span 1 year only – As stated earlier the devices are rarely used
now-a-days. This is not available in India.
4)
Device containing levonorgestrel
hormone: This device is available under the brand names
of ‘LevoNova’ or more commonly ‘Mirena’ (intrauterine dwelling time 5 years).
Instead of IUD scientists often call it as IUS (Intrauterine System). This
device is manufactured by Bayer Healthcare Pharmaceticals, Wayne, New Gersey.
It is marketed in India by German Remedies and the approximate cost in India is
Rs. 6000/-.
There are some newer IUDs which has become available recently:
In the last
two decades some newer IUDs has come in the market. They are ‘T-safe-Cu-380A’, ‘Gynae-fix’, ‘NOVA T’,
‘Flexi-T-380’, ‘Fibroplant IUS’. These are used with varying degree of
satisfaction. Sadly, such modern IUDs
are not available in our country.
Why newer devices?
For
last several decades modifications of size, shape and chemical content are
being aimed at to reduce the expulsion rate of side effects while maintaining
the exceptionally high effectiveness and safety profiles of IUDs. Reproductive
scientists are working on different frame designs too. In the process frames of
different sizes and shapes with various active substances incorporated in the
frame for pregnancy prevention has been made available. Some are still in newer
clinical trial phase. Hopefully, IUDs will bring many more options for
fertility regulation. The uterine cavity has a hollow space. However, in
reality, this space, which varies in size and shape peculiar to each woman, can
better be described as a potential cavity that widens at the tubal openings.
The area adjacent to the tubal openings is often described as being overly
sensitive for irritation, and hence, leads to increased uterine contractions
when IUDs are fitted. So scientists are trying hard to design such IUDs
which will minimize repeated trauma in these parts of uterus i.e. the most
sensitive parts.
As
on in 2004, Chinese women had 21 types of IUCs to choose from. Examples of
research on in IUC include smaller less bulky devices intended to geometrically
adapt to smaller nullparous uteri, frameless copper IUDs fixed to the
endometrium with a thread, devices with movable joints in the cross bars to
help them expand and contract with uterine contractions and adapt to different
uterine sizes and contours (geometric adaptation). Some newer devices have
cervical components and cervical anchoring systems. Still smaller devices
appropriate for the smaller atrophic perimenopausal uterus are also under
clinical trial. For detailed information on newer devices reader is requested
to refer appendix.
IUD acceptability: IUD use by Indian women:
There were
three National Family Health Survey in India. The study period were 92, 93, 98,
99 and 05, 06. The contraceptive use amongst married women aged 13-49 years and
% as per NFHS I, II & III. In these survey it was revealed that %, % and % of women used IUD.
IUD use in other Countries:
Almost 156
million married women of reproductive age worldwide use IUD. Amongst all
married women who use any family planning method as many as 20% rely on IUD.
Copper IUD is
very popular In China and 92 million of Chinese women are wearing copper IUDs.
Globally sixty percent all IUD users live in China. In China 83% of married
women use some form of contraceptive. This is commonly expressed as CPR i.e. Couple Protection Rate. Thirty six
percent of them use IUD!!!
IUD is also
popular form of contraceptive in Egypt, Mongolia, Vietnam, North Korea &
Latin America particularly Mexico. Similarly this contraceptive device is also
popular in Eastern Europe, Finland and Norway. Ten to thirty percent of women contraceptors of those countries
use IUC.
USA doctors
prefer to use IUC for themselves! In USA though the prevalence amongst general
population is only 2% but the use amongst female physicians and female
gynecologists were 5% and 9% respectively. Female fellows of the American
College of Obstetricians and Gynecologists answered that would choose IUC as
their first choice contraceptive method when childbearing was completed and as
their second choice after oral contraceptives, if desiring to space their
children. US women who have the most knowledge to make their contraceptive
decisions i.e. obstetrician/gynecologists choose IUC more frequently than their
patients.
Mode of Action as Contraceptive:
The
way an IUD works as contraceptive is not fully understood. The most recent
studies however indicate that the very presence of an IUD impedes the movement of sperm inside the womb thereby
preventing fertilization of eggs. This action applies both to inert i.e.
nonmdeicated IUDs (not available nowadays) and modern medicated IUDs.
Additionally, copper released from copper containing IUDs disrupts sperm-oocyte
interaction. We know that union between sperm and ova which occur in egg
transport tube are depended on about dozen of enzymes. Released copper ions
impair the efficacy of such enzymes involved in the fertilization process. Thus
copper IUDs acts prior to fertilization and thus it is not an abortificient per
se. Copper ions which diffuse from the copper bearing IUDs also damage the
spermatozoal enzymes system and other enzymes present in the womb necessary for
blastocyst (future embryo) inplantation. In contrast to oral pills neither
copper bearing IUDs nor the hormone containing IUDs alter ovary and function
and suppress release of eggs.
In
summary, the main effect of copper IUDs is prevention
of fertilization and even if fertilization occurs there is ‘implantation blocking effect’ which acts
as a back-up contraceptive mechanism.
Effectiveness or Reliability of IUD as contraceptive:
Modern IUDs
are very effective in preventing
pregnancy. The first year failure rate for the copper IUDs is about 1.5 to 0.8
%, which is slightly higher than that of tubal sterilization (0.5% in the first
year). The efficacy of this device can be compared favorably with ‘combined’
pills (first year failure rate 0.1%) and progesterone only pill (first year
failure rate of 2%). Fortunately, the failure rate for copper IUDs appear to be
highest in the first year and declines thereafter. Similarly pregnancy rate in
first-year perfect users are 0.8 to 0.6 and 0.1 per 100 women, in LNG-IUS users
and Copper T380A users respectively.
Life span of IUD: Intrauterine Dwelling Time: How long an IUD is going to
offer contraceptive protection after it is fitted in womb?
International
agencies differ on this issue so also the Drug Controller Authorities of
different countries. It will be prudent for the HCP to strictly follow
guidelines approved by the country in which he/she practices. For instance
Govt. of India recommend 10 year intrauterine efficacy of T-Cu 380A device (the
most popular IUD) though WHO has declared that the particular IUD is effective
for 14 years without any loss of contraceptive efficacy. The life span of other
two commonly used copper IUD e.g. Multiload Cu 375 and ML Cu 250 are five year
and three years respectively. These two IUDs are freely available in Indian
market.
Continuation Rates & Clients Satisfaction:
Women spend most of their
reproductive years on average 30 years trying to avoid pregnancy. Thus the
impact of continuation rates on contraceptive success cannot be underestimated.
IUC demonstrates high contraceptive effectiveness and it has high biologic
efficacy. It requires almost no compliance. In fact it takes a volitional act
to discontinue protection rather than to use protection. IUD has the highest
continuation rate of any reversible method.
The copper
IUD continuation rate is 78%, and the LNG IUS continuation rate is 81% at the
end of first Year of use. In contrast, oral contraceptive continuation rates at
1 year range from 50% to 68%. Although the efficacy of depo-provera is
considered top-tier, the overall continuation rate at 1 year is only 56% and is
as low as 22% in some populations.
Although
continuation rates with the two IUDs are similar, reasons for discontinuation
differ. More women discontinue the copper device because of bleeding and cramping complaints,
whereas more women discontinue the LNG-IUS device because of amenorrhea (stoppage of menstruation)
and hormone related side effects.
Overall, continuation rates are similar.
E) Advantages of IUDs as contraceptive: Why woman will opt for IUD?
12)
Immediately
effective and very little to remember subsequently.
13)
Can
be used during breastfeeding. Does not alter the quantity of breastmilk.
14)
A
single decision leads to effective long term prevention of pregnancy. IUD is a
long acting contraceptive, therefore often called as ‘forgettable contraceptives’.
15)
T-Cu
380A is distributed at no cost by Govt. of India and available even in remote
rural areas e.g. PHCS, BPHCS (Block Primary Health Centers).
16)
Less
follow up to clinic. The contraceptive induced side effects after six months
are minimal (worry free contraceptives).
17)
Requires
no attention except for monthly checks for the string (to be done by
self/husband).
18)
Does
not interrupt sex. Efficacy of this method is very high, so increased sexual
enjoyment because there is no need to worry about pregnancy or contraceptive
failure.
19)
Fertility
resumes immediately upon removal.
20)
There
are no hormonal side effects with copper bearing IUDs. In fact there are no
systemic side effects like oral pills, hormonal injections, implants or
transdermal patches.
21)
There
is no interaction with any drugs.
22)
There
are certain ailments or diseases where oestrogen hormone use is
contraindicated. Such women should avoid combined oral contraceptives which
contains oestrogen hormone. Fortunately most of them can use copper IUDs which do not contain any hormones whatsoever.
The clinical conditions when oestrogen hormone should be avoided are:
List
of such clinical situations where IUD can be safely used are 1) Heavy smokers
and or obesity 2) Diabetes mellitus of all severity. 3) Benign breast diseases
4) Migraine (IUD can be used in all types of migraine). 5) Controlled high blood
pressure if BP is upto 160/100 or even beyond 6) Thrombophilia i.e. blood
coagulation problem e.g. women with past history of deep vein thrombosis may be
fitted with IUD. 7) Past history of stroke 8) Gall bladder diseases 9) Varicose
veins 10) Ischemic heart disease 11) Hyperlipidaemia (excessive bad cholesterol
in blood) 12) uncomplicated valvular diseases of heart in absence of pulmonary
hypertension and atrial fibrillation (to be fitted with the consert of
cardiologist) 13) Depressive disorders 14) Women suffering from tuberculosis
provided tuberculosis is outside the genital organs (e.g. non pelvic
tuberculosis) 15) Diseases of the mouth of womb i.e. cervix. These are often
called CIN (cervical intraepithlial neoplasia) & ectropion of cervix.
Copper
bearing IUDs however can be safely used in above quoted conditions provided if
she does not have concomitant diseases of womb e.g. tumors, or descent of
genital organs or infections. These diseases of womb may make the client
unsuitable for IUD use. Thus HCP coming across such women with above quoted
‘systemic or general diseases seeking contraception may be motivated for using
copper IUD as first choice contraceptive and women should be counseled and made
aware of relative safety of IUD. Such counseling should preferably be done both
during antenatal visits and also during postpartum visits.
Covert use of IUD:
Husband
and some family members often do not approve contraceptive used, particularly
in rural India. This is a complex social issue involving gender inequality and
woman’s control of their own health and fertility no pane.
This
is often nowadays called ‘altitudinal
factor’ for any social problem and not limited to contraceptive non use
only. Fortunately, this contraceptive device can be used without the knowledge
of the husband and family members. In some societies social norms many make it
difficult for a woman to discuss sexual matters with her husband or adoption of
methods that control her fertility. This not only true for rural Indian women
but for slum dwellers too. This particular long-term contraceptive may be used
without the permission of husband. Covertly quarterly shots (total four doses
of injection per year) can also be taken without disclosing to her husband
provided the wife is motivated.
In summary there are three special situations
where copper IUD surpasses all other contraceptives. Firstly, it can be used in
a variety of medical diseases where hormonal contraceptives are contraindicated
and may be harmful to client. Secondly, once fitted it will offer contraceptive
protection for 12-14 years with virtually no follow up. Thirdly IUD is used
covertly without the knowledge of husband and family members. It can also be
used soon after birth (puerperal insertion of IUD) or it can be fitted after
six weeks of childbirth without affecting breast-milk production.
Candidacy for IUDs i.e. selection of acceptors: Who are the ideal women
for IUD? The most
ideal women for IUDs should have following characteristics:
7)
Have
had children but do not wish to have more by another 3-4 years time. It is not a good contraceptive where short
term contraception is planned.
8)
Have
no history or clinical evidence of pelvic infection e.g. pelvic pain, white
discharge or dyspareunia etc.
9)
Have
no history of sexually transmitted infections (S.T.I.).
10)
Have
only one sexual partner.
11)
No
uterine tumor or distortion of womb.
12)
No
dysmenorrhoea or menstrual irregularity.
IUD can be
used in women who had ectopic pregnancy earlier. The absolute risk of ectopic
pregnancy is extremely low due to high effectiveness of IUDs. However when a
woman becomes pregnant during IUD use, the relative chance of ectopic pregnancy
as compared to uterine pregnancy is considerably increased.
Poor candidates for IUDs: Contraindication of IUD as a contraceptive:
j)
Recurrent or current pelvic infection (PID). This is the most important
contraindication for IUD use. But IUD can be used if there is one pregnancy
after an attack of PID and there is no
risk of acquiring S.T.I.
k)
behavior
of the acceptor or her husband is so that there is a fair chance for acquiring sexually transmitted disease.
It any of the spouse has multiple sex partners then ideally sexual copper
bearing IUD should not be fitted. Hormone containing IUDs may however will be a
better option.
l)
Those
who are already suffering from menstrual
cramps and/or heavy periods. Hormone containing IUC (Mirena) may be
beneficial in such women. Such IUD will serve the dual purpose of contraception
and disease transmission.
m)
Similarly
those who are suffering from abnormal
bleeding or anemia are also not good candidates for IUD.
n)
Part
history of ectopic pregnancy: It is better to avoid IUD for those group of
women though opinion differs. Now only a few gynecologists believe that IUD
should not be fitted in such women.
o)
Uterine Fibroids hormone containing IUDs may however
be used. According to WHO if myomas do not distort the uterine cavity then
copper IUD may be used if no other suitable contraceptive is available?
p)
A
very large/small uterus and other anatomical abnormalities of womb.
q)
Obvious
cervical or uterine cancer.
The assessment of suitability of IUD is done in stepwise manner. e.g. -
4)
Replies
by the client in response to some question.
5)
Clinical
examination by the HCP.
6)
Laboratory
lists to desires exclude STI.
Checklist (question) for screening clients who to initiate Use of the
copper IUDs:
Intrauterine devices (IUDs) are generally safe and effective for use by
many women, including those who have not given birth, who want to space births,
and those who are at risk of HIV infection or living with HIV infection. But
some women are unsuitable for IUD due to the presence of certain female
diseases, such as current cervical infections (infections of the mouth of the
womb), PID or other diseases of womb (uterus). For these reasons, women who
desire to use an IUD must be screened for associated gynecological
conditions to determine whether if they are appropriate candidates for the IUD.
It no such screening is done prior to IUD insertion then post insertion
complications will increase considerably which must be avoided by all means.
The
checklist consists of a series of questions planned to identify any medical
condition or behavior that would either prevent safe IUD use or require further
screening in the form of investigation. As well as provide further guidance and
directions based on client responses. A health care provider should analyze her
response to all questions before inserting an IUD and thus assess eligibility
of IUD use.
Answers to be replied by prospective acceptor:
10)
Have
you given birth within the last 4 weeks?
IUD should be fitted after 4 weeks of childbirth and not before.
11)
Have
you been told that you have pelvic tuberculosis or any type of cancer in your
genital organs?
12)
Do
you have bleeding between menstrual periods that is unusual for you or bleeding
after sex?
13)
Within
the last 3 months, have you had more than one sexual partner?
14)
Within
the last 3 months, do you think your partner has had another sexual partner?
15)
Within
the last 3 months, have you been told you have an STI?
16)
Within
the last 3 months, has your partner been told that he has an STI or has he had
any symptoms for example, penile discharge?
17)
Are
you HIV positive?
18)
Have
you developed AIDS?
e)
If
answers to Q No. 3 are yes then it implies that she has probably some female
(gynecological) disease then she should be treated for that specific disease
and IUD fitted at a later data with the approval of gynecologist.
f)
If
answer to any of the questions 4 to 7 is affirmative then also IUD should be
avoided. IUD can be fitted after cure of suspected gonorrhea or Chlamydia
infection (STI)
g)
If
answer to Q 8 is yes and there is no evidence of AIDS disease then she can use
IUD.
h)
If
answer to Q. 9 is yes then IUD may be used if she is doing clinically well on
ARV drugs (antiretroviral agents). But if she is not on ARV then IUD should not
fitted.
Additionally,
no pregnant women should be fitted with IUD. Pregnancy can be excluded by home
monitoring of urine for pregnancy test after the expected date of period in
over. But occasionally such kit may not be available in remote areas of India.
Then putting the following questions to the acceptor can reasonably assess
whether she is pregnant or not. These questions will also give a possibility of
having pregnancy in the running cycle before the expected date. Pregnancy is
almost always impossible under the following situations.
5)
She
has abstained from sex since last period.
6)
She
has given birth in the last four weeks or she had an abortion in last two
weeks.
7)
The
baby is less than six months age, and she is fully or nearly fully
breastfeeding and has not resumed menstruation as yet (Lactation Amenorrhea
Method).
8)
Pregnancy
is also unlikely in the current cycle if she was using a reliable contraceptive
‘consistently and correctly'.
B) Pre-insertion clinical examination by the
HCP:-
6)
Is
there any ulcer on the vulva vagina or cervix?
7)
Is there purulent cervical discharge?
8)
Does
the cervix bleed easily when touched?
9)
Were
you unable to determine the size and/or position of the uterus?
10)
Is
there any ‘motion tenderness’ i.e.
movement of cervix does the client feel pain in her lower abdomen when one move
the cervix sideways?
C) Laboratory investigation to exclude STI:
Is it essential to screen all women for STI if she desires for IUC? Gonorrhea and Chlamydia are the too
common STIs which cause immense local damage in genital organs. There are many
other fatal and nonfatal STIs which do not primarily affect the genital tract
but cause damage of other parts of body e.g. syphilis, hepatitis B, HIV etc.
etc. So far as screening for fitness of IUD is concerned on should ?????? on
gonorrhea and/or Chlamydia only but screening for STIs should be individualized
to the patient population. For instance evidence does not support routine
screening for gonorrhea and chlamydia in populations
at low risk of STIs. Factors that indicate high risk include history of a
new sexual partner, age under 25, or recent history of STIs. If screening in indicated, it can be done at the
time of the insertion, and the patient can be called for treatment and
encouraged to employ dual form of protection IUC for pregnancy protection and
consistent condom use for STI prevention.
Side
effects and/or complications of IUD are minimal if the acceptors are properly
selected. Properly fitted IUD in eligible women rarely cause any annoying side
effects. Occasionally there can be missing of threads and irregular vaginal
bleeding with or without pelvic pain and only on rare occasion there can be
accidental pregnancy (uterine or extra uterine). Pelvic infection is also a
possibility which has been long debated. This is particularly time if the
couple dies not maintain a monogamous relationship. All these complicates are
discussed at length.
Timing of insertion: When to get an IUD fitted?
C)
With
no evidence of recent pregnancy –
e)
Within twelve das of commencement of menstrual period : A woman can be fitted with IUD
within first twelve days of commencement of menstrual bleeding. The device offers immediate protection
and no additional protection is required in that cycle even if she had
unprotected sex in that cycle prior to the insertion of IUD.
Probability of an existing pregnancy
is extremely low before day twelve of the menstrual cycle, based on the
extremely low risk of ovulation before day eight and the 5-to-7day emergency
contraceptive coverage effect of copper bearing IUDs.
f)
Any day of menstrual cycle : IUD can also be inserted at any time during menstrual
cycle at her convenience if she is reasonably certain that she is not pregnant
i.e. either she had no coitus in that cycle or had coitus with due protection
e.g. condom or were under cover of oral pills.
g)
During amenorrhea provided urine test for pregnancy is negative: Amenorrhea i.e. cessation of
menstrual period six months a beyond may be due to pregnancy, lactation or due
to some gynecological, endocrine or nor commonly psychological facts. IUD can
be fitted if amenorrhea is due to endocrine, psychological or local (uterine)
cause and no harm will result. But results from international clinical trials
do not confirm this belief and IUD insertion is quite safe six weeks after childbirth. The only care that HCP (Health Care
Providers) should exercise is that uterine size must be determined carefully by
bimanual examination and by passing a uterine sound (a thick flexible wire)
into the uterus. Because at this stage womb is often small, therefore, a small
sized IUD like ML Cu 250 (short), ML Cu 375 (short) or NOVA T (if available)
may be the better choice. Standard size IUDs may however be chosen in lactation
period, after resumption of menstrual period.
h)
Emergency
IUD insertion as post-coital contraceptive: Use of copper containing devices as
emergency contraception is safe and effective and can help prevent unintended
pregnancy if used within 120 hours of unprotected intercourse. Emergency
contraceptive pills (ECPs) containing only levonorgestrel are also effective
and have fewer side effects.
The advantages of the IUD as
a post coital method are its high efficacy and the fact that it can be used up
to seven days after coital exposure. For certain parous woman it is the method
of choice if the women desires to use the IUD as her angoing method of
contraception. At this time the women is highly motivation. It is particularly
appropriate for the parous women with a single sexual partner who is at a high
risk of pregnancy due to failure of a barrier method. It also is appropriate
for a woman who has been sexually inactive for some time and suddenly finds
herself in an unprotected and unplanned sexual relationship (source: OUTLOOK).
The efficacy of
copper-relasing IUD as emergency contraception is very high. It can reduce the
chance of pregnancy by more than 99% when inserted within 5 days after
unprotected intercourse.
This method may be
particularly useful when the client is considering its use for long-term
contraception and/or when the hormonal regimens are less effective because more
than 72 hours have elapsed. When using on IUD for emergency contraception, the
eligibility criteria are the same as those for regular use of these device.
Making emergency contraception more widely available can be an important step
in preventing unintended pregnancies.
D) In postpartum period –
iii.
Insertion of IUD in immediate Postpartum period & after abortion (soon after vaginal delivery i.e. at
Labor Room) IUD can be fitted Postpartum insertion within 48 hours of delivery
is a recommended procedure with all safety. Though postpartum insertion is not
popular in India but in some countries this procedure is being accepted by the
women and community.
How the
programme can be made effective in India too? To be effective counseling of the
couple should start in antenatal visits since a woman may have difficulty
making a carefully considered decision about contraceptive use while she is in
labor pain. Further, help of a HCP who is specially trained in postpartum IUD
insertion must be available when a woman delivers which is not an easy
proposition in India. The major disadvantage of postpartum insertion is the higher expulsion rate and increased
probability of perforation of uterus. The IUD is more easily expelled after
childbirth because the uterus (womb) is frequently contracting and the cervix
(mouth of the womb) remains partly dilated. Surprisingly, expulsion rates
following postpartum IUD insertion are lowest
when the IUD is inserted within 10 minutes after the expulsion of the placenta.
Placement of IUD correctly i.e. high in the fundus is mandatory to minimize
expulsion. When a copper T IUD is inserted within 48 hours after delivery by an
experienced provider, expulsion rates at six months ranges from 6 to 15 per 100
insertions and the health care provider’s skill and experience are probably
very important to minimize of expulsion rate and other complications.
Technique of insertion
of IUC soon after childbirth
The process
of introduction of IUD is techmiquelly a bit different at this stage. One can
use a specially devised long insert for
post partum insertion. Sounding the uterus should be avoided because of the
risk of perforating the soft uterus. IUDs are usually inserted in immediate
postpartum period by hand rather than with a standard inserter. Immediate
postpartum insertion of the IUD can also be done by means of a sponge holding
forceps. However if the inserter is used at all then the arms of T-shaped IUD
should be released from the inserter once it has passed the cervical canal.
Then the open IUD can be lifted up to the fundus. The uterus may be massaged to
imitate a contraction so that wall of womb becomes relatively firm thus
preventing perforation.
The
disadvantages of immediate postpartum insertion of the IUD is its higher
expulsion rate and uterine perforation, Therefore most authorities advocate
insertion after 4-6 weeks of delivery. Insertion between the time period 48
hours to six weeks after childbirth carries an increased risk of sepsis and perforation.
Many therefore advise against inserting IUDs during this period.
During caesarean Section:
Occasionally
a woman can fitted with an IUD at the time of delivery by abdominal route. In
these settings possibly it is the Obstetricians choice rather than acceptors
decision, but when there has been prolonged labor or premature rupture of
membranes, insertion during caesarean operation should be avoided because of
the risk of infection.
Role of antibiotics in
immediate postpartum period:
There is
still debate about routine use of antibiotics after fitting an IUD. The present
consensus is not to use prophylactic antibiotics routinely in all cases.
However, in settings of both high prevalence of STIs and limited STI screening,
facility such prophylaxis may be considered or else HCP may counsel the IUD
user to watch for symptoms of PID, especially during the first month. If
symptoms appear (pain, fever, white discharge) then one can prescribe
antibiotics.
ii.
During lactation period without having restoration of menstrual period: IUD can be fitted if urine for
pregnancy test is negative but this should be fitted at least six weeks after
childbirth. Earlier, there was some concern that insertion during lactation
might involve a higher risk of uterine perforation as the womb is still small
and soft.
iv.
IUD insertion after abortion –
IUD can be introduced after surgical evacuation of
uterus (abortion) if there is no sepsis.
Insertion during
postabortal period
r)
When
abortion occurs/contemplated before 14 weeks of gestation -
IUDs can be safely inserted during evacuation of the
uterus (surgical abortion). Provided the pregnancy is less than 14 weeks. The
couple should be made aware that conception can occur as early as 10 days after
abortion. Therefore effective contraception is needed soon after abortion. IUDs
can safely be inserted after spontaneous or induced abortion except in women
with evidence of pelvic infections or septic abortion.
WHO studies
show moderate expulsion rates associated with IUD insertion following first
trimester abortions – ranging at two years from 5 to 9 per 100 women after
induced abortion and from 10 to 14 after spontaneous abortions.
ii) When
spontaneous abortion occurs or Medical Termination is contemplated between the
period 14 weeks to 20 weeks pregnancy. It is not customary to fit IUD after
second trimester abortion (14-20 weeks of pregnancy). Because there is 5-10
times more chance of expulsion of the IUD is being inserted immediately after
second trimester abortion (WHO Task Force Study, 1985). So it is better to wait
for 4 weeks or till the next period ensue whichever is earlier.
Safety Concerns: It is a safe contraceptive though
misperceptions about the risks associated with IUD use are well documented.
Although every contraceptive intervention has its risks, including failure and
the much greater medical risks associated with pregnancy and childbirth, the
overall safety profile of modern IUC is among the best in the contraceptive
armamentarium.
When to consult HCP; Warning symptom s & Signs while with IUD:
One
needs to call a health care provider immediately if any of the following
symptoms or abnormalities appear e.g.
8)
String
can no longer be felt, possibly the device has fallen out of womb.
9)
Something
hard is felt in her vagina or at the lower end of cervix. It means that one is
palpating the lower part of vertical arm of the device. It the device remains
at its proper place then it can neither be seem by HCP nor can be felt by the
acceptor. Therefore if device itself becomes palpable it implies that device
has come down and possibly is on the way of expulsion.
10)
Strings
seem shorter: It may imply that the device might have undergone some rotation
on long axis of womb and has coiled up in the womb. If the string seems longer
than before it may imply that device has started to descent while the device
still remaining in the womb.
11)
A
missed or a late period, a very light period, severe cramping and/or abdominal
pain which was not experienced earlier may mean pregnancy outside the womb i.e.
ectopic pregnancy.
12)
Client
considers that she has been exposed to STD.
13)
Bleeding
during intercourse or,
14)
Foul
smelling vaginal discharge (acute pelvic infection i.e. infection of upper
genital organs).
If any such situation arises then the
acceptor should consult HCP within couple of hours.
Management of possible side effects of the IUD:
The list of possible side effects associated with IUD use are:
vi)
Uterine
Cramps
vii)
Menstrual
irregularities
viii)
Pelvic
infection
ix) Spontaneous expulsion
x)
Accidental
Pregnancy
Many
do not have any adverse effect at all and keeps fine. That is also why the IUD
called worry-free contraceptive a forgettable contraceptive. Only few have
symptoms and a few are bothered or distresed with side effects. The common
discomfort quoted by the acceptors are ‘bleeding irregularities’ and ‘pelvic
pain’. Why some women have side effects and other women escape? Firstly, health
care providers need to know that not all women are suitable for IUD. Therefore
if the acceptors are not properly selected then IUD related side effects will
be more. For instance if there is pelvic infection, or uterine abnormality then
side effects are bound to occur. If IUD is fitted inadvertently in such women.
Side effects thus can be minimized by proper selection of clients and strictly
adhering to contraindications of IUD use as framed by W.H.O. and other
international agencies. Secondly, these side effects can be further minimized
if the IUDs are fitted by an experienced and skilled nurse or doctor who has
adequate training on IUD insertion. The
cause of cramps in lower part of tummy either during menstruation
(dysmenorrhoea) or in between periods are often caused by slight malposition or
malrotation of IUD inside the uterine cavity (womb). The pain is usually
relieved by usual analgesics and NSAIDS. Persistene pelvic pain however may not
only be due to abnormal position of the IUD associated PID, but also
occasionally uterine perforation, beginning of expulsion of the IUD, or rarely
ectopic pregnancy may also be the cause pelvic pain. One has to remember that
womb is a hollow muscular organ and constantly undergoes contractions and
relaxation. During a height of continue muscles of uterus pres the device
particularly if it the device is not properly fitted. This may recurrently
cause cramp in lower part of belly and irregular bleeding. Scientists have now
devise newer frames with flexible joints in the transverse bar of ‘T’ device
which allows the IUC to repeatedly yield and accommodate the changing shape of
womb with each contraction and relaxation sadly, these devices are still not
available in the market.
IUD induced menstrual disturbances (Bleeding related problems):
Variety of
menstrual disorders which however occasionally quoted by the acceptor are as
follows. 1) Spotting between periods i.e. inter menstrual bleeding 2) heavy
periods or longer menstrual flow (menorrhagia). These menstrual aberrations
usually last for first three months after insertion of IUD and fortunately most
of these subside by three to six months time. Only in few cases HCPs (Health
Care Providers) are forced to remove the IUD if the magnitude of suffering is
considerable persistent or non relieved by drugs.
j)
Incidence
and severity of bleeding: In a normal
menstrual cycle i.e. without any IUD, the mean amount of menstrual blood loss
(MBL) was previously thought to be approximately 35 ml. With improved
techniques of extraction of blood from sanitary napkins, this amount is now
estimated to be approximately 60ml. Excessive or prolonged menstrual bleeding
(menorhagia) affects between 5% to 30% of women of reproductive age i.e.
general population not using contraceptives. It is more common among women
under the age of twenty and over the age forty years than.
The amount of blood lost in each
menstrual cycle is slightly greater in women using copper-bearing IUDs than in
nonusers. With the most commonly used IUD there is only an average increase of 20-55% in MBL which most women accept. By
contrast, with the leonorgestrel releasing IUD (Mirena IUS) which is now used
in India for last 5 years the amount of blood loss is significantly reduced,
declining to approximately 25ml/cycle.
k)
How to gaze severity of bleeding? A personal interview
and total number of napkins needed per 24 hours will often help the HCP to
assers the severity of bleeding. If a woman who is on IUD complaint of weakness
in addition to excessive bleeding then HCP can think of chronic anemia due to persistent heavy bleeding. In absence of any
other evidence of blood loss e.g. piles, worms infestation and haematemesis the
possibility of IUD induced anemia
should always be considered. It implies that menstrual bleeding is too much to
cause anemia. In these cases the HCP should insist on hemoglobin estimation. If the level is below 9gm% then he (HCP) can
request for estimation of serum ferritin
level in blood provided such laboratory facilities exists in the locality
in which the client resides. Serum ferritin is a very sensitive indicator of
tissue iron stores. Persistent menorhagia without concomitant iron
supplementation is likely to cause significant decrease in serum ferritin
levels. Low blood ferritin is an indicator of depletion of iron store in the bone
narrow as well. Therefore a conscientious HCP may occasionally request for
ferrtin estimation amongst women with menstrual bleeding disorder and levels
less than 4mg/lit should always require oral iron supplementation to prevent
further anemia.
l)
Why bleeding and pain? As said earlier most bleeding
irregularities including painful cramps occur due to inproper fitting of IUD.
If there is slight tilt or rotation of IUD inside the womb or angulation between the long axis of womb and
long axis of IUD then device will lead to repeated mild trauma in the inner
wall of womb and induce pain and menstrual bleeding. We know that muscle of
womb contracts and relaxes at definite intervals even in nonpregnant state. If
the device inside the womb is ill fitting then it will hinge the inner wall of
womb and induce pain and bleeding during height of contractions. A simili can
be drawn with small foreign body (fishbone) stuck at throat which causes pain
during each act of swallowing unless the fishbone passes down (antoadjustment)
or removed.
In addition to ill-fitting the other causes of pain and excessive bleeding
are due to – i) P.I.D. ii) at the beginning of expulsion of IUD iii) associated
PID or ectopic pregnancy (tubal pregnancy) All these may cause pelvic pain and
bleeding. Hence persistent pain or bleeding should be always investigated
properly by the experts.
m)
How to prevent bleeding: Besides selecting the
acceptor the proper selection of appropriate sized IUD and proper placement of
IUD by a skilled person are key factors to minimize bleeding related side
effects. Researchers have now been able to devise new devices which cause minimal menorrhagia (excessive menstrual
loss). These new IUDs have also succeed in reducing the likelihood of expulsion
and lowering of pregnancy rate further. It is hoped that future designs of IUD
will focus on reducing these side effects even further.
n)
How to treat pain and bleeding: For short-term relief
three types of drugs are used with varying success. These are tranexarmic acid,
NSAIDS or mefanamic acids with varying success. One can try with tranexamic
acid, 500 mg 3 times daily for three days and then 500 mg twice daily for 2 day
particulars during heavy or prolonged bleeding phases. This drug is available
as Pause 500, TX 500 etc. Alternatively, NSAID group of drugs e.g. ibuprofen
(400 mg), indomethacin (25 mg) two times daily may be tried. Mefnamic acid
tablets are increasingly used nowadays. These should be taken twice daily after meals for 5 days
and this may ameliorate heavy or prolonged bleeding. These are available as
ponstan 500 or meftal 500 etc.
Some doctors do prescribe these
nonsteroidal anti-flammatory drugs (NSAIDS) e.g. ibuprofen, mufanamic acid etc.
prophylactically i.e. from the onset of first menses after IUD insertion and
maintain such schedule for three to five consecutive days. This by decreasing
pain and bleeding certainly increase clients her confidence on IUD. NSAIDS
therefore prescribed in anticipation will yield a dividend most cases.
Occasionally these drugs will not
work and heavy or prolonged bleeding persists. If there is no reason to suspect
on underlying local i.e. gynecological cause of bleeding, there are two
options. Firstly she can continue using IUD method and in that event she should
take iron tablets and/or eat foods containing iron, to help prevent anemia.
This policy, however, is only acceptable when pain and bleding is partly
reduced by above mentioned drugs and the woman is not that distressed with pain
and bleeding. But if she shows signs of severe anemia and severity of bleeding
is unacceptable then one should remove the device and advise her to choose
another method.
Removal due to pain and bleeding is
less common among older women, multipara and in long-term users. The removal
rate depends a lot on the preinsertion counseling and support that a woman
receives and on her altitude, both familial personal, towards her trouble with
IUDs.
How does bleeding affects general
health of a woman? The effect of bleeding is almost nil in healthy women but
may lead to increased anemia already anaemic woman. Indian National Family
Health Survey-3 (study period 2005-’06) has unearthed the fact that 39% of
Indian women are mildly anaemic haemoglobin level <10 to 10.9 gm/d and 16%
are moderately anaemic. There is of women by 4% the
period 1098-99 to 2004-05. <70-9.9 gm (d) and 2% are severely, anaemic (H
level 7 g/d).
Anaemic usually passes off within a
month or two. The client should be reassured about it. In fact, no aggressive
treatment is warranted.
o)
Removal Rate: The single most common side effect leading to
IUD discontinuation is disturbance in menstrual bleeding. The experience of
excess bleeding is often accompanied by pain also. These two side effects
either alone or in combination are not too uncommon. Inspite of adequate
counseling and medical treatment in 2-10% of cases IUD have to be removed for
persistent menstrual bleeding and pelvic pain. Providers should always offer
clients the choice of switching method if they are not satisfied or if their
needs or preferences have changed.
p)
How women and society view about normal menstruation?: Women’s
attitudes about menstruation are shaped not only by experience but also by
beliefs about the social and cultural meaning of menstruation and what is
acceptable monthly bleeding, taboos, and behavioral restrictions. Although not
all belifs are reflected in practice, in many places cultural and religious
beliefs prevent menstruating wome from participating in worship, sex, domestic
works and many social activities. In some societies menstruating women should
not visit places of worship. In some conservative societies menstruating women are
not allowed to perform event heir domestic chores such as cooking and washing
clothes. Sexual intercourse should be avoided during monthly bleeding. In
contrast, only about half of women in the united kingdom, the only developed
country in the study, believed sex should be avoided during monthly bleeding.
Even among women who thought that it was acceptable, however, many did not have
sex then as a matter of personal choice.
q)
How a woman react to menorrhagia?: If is retreated that these bleeding changes are rarely
harmful, and they do not signify underlying or impending illness. But a woman
reacts to bleeding changes and to what extent one tolerates depend on many
factors, such as on the type and severity of bleeding changes and how severe it
is, or whether it interferes with her daily activities or personal
relationship, and also traditional beliefs or restrictions surrounding bleeding
days. These changes however are not signs that something is wrong with her
health. It is not the bleeding change itself, but rather how the woman feels
about it and interprets it that will determine how she reacts. It should be
stressed that these bleeding changes are normal and not signs of serious
illness.
r)
Do other contraceptives cause such bleeding?: Bleeding
and spotting at unexpected times are also common among women using oral
contraceptives (20% of cases particularly during the first three months). The
good news is that this drop to about 10% of cycles during the next three
months, and to approximately 5% of cycles during the last six months of a
12-month period.
In summary, the following information
may help the clients.
b) Spotting or light bleeding b) Heavier
or longer menstrual
between menstrual
periods. bleeding than normal
(not amounting to
anaemia) menstrual periods.
(The amount
blood loss is such that there is a
threat for becoming anaemic)
|
e)
HCP should
counsel that spotting or light bleeding is common during the first 3-6 months
of copper-bearing IUD use. It is not harmful and usually decreases over time.
|
c)
The following
treatment should be offered during the days of menstrual bleeding.
Non-steroidal
anti-flammatory drugs (NSAIDS) or Tranexamic acid haemostatic agent). Aspirin should not be used.
|
|
f)
If she desires treatment,
a short course of non-steroidal anti-flammatory drugs (NSAIDS) may be
prescribed during the days of bleeding.
|
d)
If bleeding
continues to be very heavy or inspite of blood coagulating agents and there
are clinical signs of anaemia, or if she finds the bleeding unacceptable,
early removal of the IUD is the best option.
|
|
g)
If women is
bothered with persistent spotting and bleeding then one should exclude other
gynecologic problem. If a gynecologic problem is identified, it should be
treated by a specialist. There is no need to removel IUD.
|
|
|
h)
If no
gynaecologic diseae can be held responsible for bleeding, and she finds the
bleeding unacceptable removal of the IUD should be done and one should help
her to choose another method.
|
|
(Courtsey: World Health Organisation)
3. Pelvic infection (PID-Pelvic
inflammatory disease):
Female
genital organs are arbitrarily divided into two compartments e.g. lower genital
tract and upper genital tract comprises of external genitalia (vulva) and birth
canal (Vagina). The upper genital tract comprises of womb (uterus and its mouth
i.e. cervix), fallopian tubes, with i.e. egg transport tube which carries eggs
from egg relasing organ (ovaries) to womb.
PID is the
infection of upper genital organs. The abbreviation ‘P.I.D.’ stands for ‘Plevic
Inflammetory Disease’. There are many organisms responsible for PID. Some
organism responsible for sexually transmitted diseases can also cause PID. Poor
hygiene, under-nutrition, pelvic tuberculosis and above all repeated induced
abortions can initiate PID. Abortion can procedure even if carried by experts
in an clean environment can result PID. So surgical abortion is not cent
percent safe and should be avoided as far as possible. The long term ill
effects of PID are chonic pelvic pain. low backache. Infertility or pregnancy
in fallopian tube, i.e. ectopic pregnancy. The very anatomy of fallopian tube
and crypts in cervix are such that any infection in these areas are difficult
to cure by drugs surgery permanent.
Coming to the
question of whether IUD inserted inside the womb will invite PID or not was a
debatable issue. Opinion of scientists still vary people have different views.
In the decades of seventies and eighties both reproductive scientists as well
as acceptors of IUD firmly believed that the risk of genital infection will
remain high during the entire period of IUD wearing. In the 1992 international
conference on IUD critically analyzed the review published by WHO which was
meta analysis (summary of many studies analyzed together) involving nearly 22,
908 IUD users (using a total of 10 different IUD types) around the world.
Result of that reviend supports the relative safety of IUD use so far as PID is
concerned. All the researchers unanimously and firmly concluded that copper IUDs
do not promote PID.
Metaanalysis
also point that PID rates were highest among young IUD users in certain
geographic regions. PID rates were high among IUD users in Africa and lowest in
China were bilateral monogamy is the usual rule.
The observers
who were in charge of analyzing such data finally concluded that much of the IUD associated PID occurs in women who
are at higher risk of STD infection, i.e. primarily women with more than one
sexual partner or whose partner has other sexual partner.
To summarise on the issue of IUD
induced PID’ it may be infersed that a) overall, the rate of PID among IUD
users was very low (1.6 cases per 1,000 woman years of use) b) the rate of PID
was highest during the first twenty days after insertion (9.7 cases per 1,000 insertion)
and remains low and stable thereafter (0.5 to 1.4 cases per 1,000 woman years
of use) c) some physicians employ preventive antibiotics before inserting the
IUD, but the meta analysis did not find that this was helpful. d) twenty days
after insertion of IUD the risk of PID remain very low, even among users who
had an IUD in place for eight years or more. In the event the woman develops
evidence of genital infection (P.I.D.) while on IUD it is not necessary to
remove IUD. Instead potent antibiotics should be prescribed in consultation
with HCP. Removal of the device during the infection does not ameliorate her
symptoms or modify the course of PID in any way. IUD, however can be removed if
the client so demands or if evidences of infection do not subside inspite of
adequated treatment for reasonable period of time.
Spontaneous expulsion of IUD and management of missing thread:
The
management of such complications is detailed below and a knowledgeable acceptor
can react readily if such mishap ensues.
An
estimated 2% to 8% of IUDs are expelled from the uterus within the first year
of use. After insertion of IUD there is a natural tendency of uterine
contractions to push the device (a foreign body) downwards, causing partial or
complete expulsion though the T-shaped frame itself and the irregularity
present in the T-arm prevent downward displacement of IUD.
Expulsion
is most likely to occur during the first three months after insertion. Several
factors influence the chances of expulsion. Young mulliparous women have higher
expulsion rates for all devices than parous women. After the first child there
is a negligible effect of increasing parity on the expulsion rate. However, IUD
expulsion rates seem to decline in a fairly linear fashion with increasing age.
Women who had painful menstruation or abnormally large menstrual flow are more
prone to expel copper-T-IUDs. The main increase in expulsion rate occurs when
IUDs are inserted during the menstrual flow and is probably linked with extra
myometrial activity (muscles of womb) at that time due to presence of excessive
prostaglandins (a chemical agent).
What is the advice for acceptors?
All acceptor
should palpate the thread after cessation of each menstrual period. If client
is unable to feel the string herself she should seek help of HCP. Till then she
should use some other contraceptives Similarity if the client can feels the
plastic part of device it means that device has slipped down and then also she
should visit HCP. Thus if the client can feel the lower part of frame in the
cervical canal (neck of the womb to be more precise) then possibility of threatened expulsion is suspected, and
she should immediately consult HCP. HCP too if cannot feel or visualize the
string then the provider should consider three possibilities.
d)
The
IUD has fallen out of body without the knowledge of the acceptor. This may
happen during menstruation, defecation or urination.
e)
The
IUD has changed its position inside the womb (coiling up) and in the process it
has drawn string upwards inside the womb.
f)
The
least possible cause is its perforation inside tummy (very rare).
What HCP will do in such situation?
In
this situation, after pelvic examination has been performed and the possibility
of pregnancy excluded by urine test an ultrasonography
should be done which will confirm or refute the position of IUD inside the
womb. Ultrasonography can enrich us with three types of report e.g. a) The
device is still inside the womb (coiling of IUD). In such situation the device
should be removed by a minor operation e.g. hysteroscopy or more D & C
depending on the expertise of the surgeon. A fresh device may be inserted if
the couple commonly dicers. b) Device but has perforated the uterus and is in
tummy. If sonography confirms that the device has gone inside the belly then it
should be removed by laparoscopy. c) More commonly the sonography will reveal
that there is no IUD either inside the womb or inside tummy. Then it may be
inferred that device fallen out of the body. In such case another device may be
fitted provided woman agrees else couple can opt for some other contraceptive
method of their choice.
In
all such cases where string can’t be palpated a postcoital contraceptive should
be considered if she has recent sexual activity and a backup contraceptive
should be adopted till another contraceptive selected.
Limitations as a contraceptive:
10)
Side effects in some women in the form of pelvic
cramps and irregular bleeding.
11)
Spontaneous expulsion of IUD: IUD
may be expelled spontaneously from the womb without the knowledge of the woman
in up to 10% of women. This will be evidenced by inability of the woman to feel
the string of IUD in the upper part of birth canal. The expulsion rate of IUD
during first year of use is high and it is rare to have IUD expelled after
first year of use.
12)
Invites infection to genital tract: There
was a longstanding debate whether presence of IUD inside the womb invites
infection to cause P.I.D. (pelvic inflammatory diseases). Now different
international studies have proved that in monogamous relationship IUD does not promote P.I.D. Still many
skeptic scientists do not recommend IUD insertion in nulliparous women in care
there is IUD induced infection which may lead to infertility in later life and
according to them IUD is not a good choice for nulliparous women (category 2
risk). But many unmarried or nullparous married women have been fitted with IUD
and results are encouraging. We will have to wait to see whether IUD can still
be used in polygamous women and nulliparous women but certainly the old belief
that IUD incucing PID is fast fading.
13)
Discomfort during fitting: Insertion
of IUD requires a minor medical procedure which may be somewhat uncomfortable
particularly who are apprehensive.
14)
No preventive action on STI: Contraceptives
are primarily viewed as method of pregnancy prevention rather than STI
prevention. Most women especially those who are married or in stable
relationships choose methods to prevent pregnancy rather than to prevent STI.
As IUD does not offer STI protection hence women should use her own judgement
regarding necessity of condom use in addition to IUD in their married life. She
can use barrier method in and for many women suggesting condom use is difficult
since condoms are often associated with commercial sex rather than marital sex.
15)
Stoppage of method necessitates
medical help: Unlike barrier methods or oral pills client
cannot stop using IUD of her own. The woman should never try to pull the string
herself. She has to go to a clinic for removal of IUC.
16)
Compared
to combined oral pills there is slightly increased
risk of ectopic pregnancy i.e. pregnancy occurring is fallopian tubes, but
this risk is less than women not using any contraceptive whatsoever.
17)
Rarely
perforation of uterus may follow and device can go inside to the tummy (very
rare indeed).
18)
Misplacent of IUD: An
IUD can descent while still remaining inside the womb and thus occasional
failure i.e. accidental pregnancy can follow. In fact contraceptive failure may
be due to expulsion, perforation, descent or coiling up of the device inside
the womb.
Risk stratification of women as per WHO guidelines:
Women
with some associated gynecological or medical diseases face some risk if IUD is
fitted. The anticipated risks or dangers are graded as 1,2,3 & 4. Earlier
people used to categorize the risk of contraceptive use as obsolete
contraindication and relative contraindications. Nowadays category risk 1
implies no risk and category 2 risk means slight risk (relative
contraindication). Category 4 means absolute contraindication and category 3
implies it is better to avoid the choiced contraceptive in that particular
diseases.
WHO risk categorization of IUD use is as follows:
C)
Category 1 risk: The
existing medical or gynecological disease does not cause any harm to client
neither it intensify IUC related side effects.
D) Category 2 risk:
i)
Age
menarche to women.
j)
Endometriosis
k)
Menorrhagia
l)
History
of previous pelvic infectious diseases without subsequent pregnancy and
assuring that there is no current risk factor for STD.
m)
Vaginitis
including trichomonal vaginitis and bacterial vaginosis
n)
Thalassaemia
& iron deficiency anemia
o)
Complicated
valvular diseases of heart
p)
Soon
after second trimester abortion.
Uterine pregnancy:
A.
Causes of pregnancy:
d)
This
unfortunate event usually follows when the device
has fallen off the body without the knowledge of the acceptor.
e)
Pregnancy
may also occur if the device is coiled up
inside the womb i.e. upward displacent of the device but the device still
remaining inside the womb. HCP should always remember that to have desired
contraceptive effect the IUD should be so located that it almost touches the
top part of womb. This area is medically called fundus of uterus. If the device
is coiled up inside the womb then copper ions will be released low down in the
womb and contraceptive efficacy with fall.
f)
If
device has descended downward i.e. in
the lowermost part of womb thereby vertical limb of the device lying in the
cervical canal.
B.
How to minimize accidental pregnancy:
As mentioned earlier spontaneous expulsion of IUD or malposition of the
IUD can often be minimised if IUD is inserted by a HCP who has adequate
training and skill in IUD insertion. Correct high placement of IUD is a prerequisite for proper achieving near 100%
contraceptive action. But the author has witnessed about six dozen of such
cases where the device which was inserted by a skilled doctor has descended
down still remaining in the womb. This is possibly unavoidable and happens due
to contractions of uterus. Normal uttering contraception’s sometimes succeed in
pushing the device down particularly if the uterus is relatively large in size.
A six monthly ultrasonography may detect the correct position of IUC in womb
and can alert the HCP & client that the device has started falling from its
original location. The other ill-effect of decent of IUD is that if the deice
comes down then copper ions released will be well below fundus of uterus. This
will be unable to exert desired contraceptive effect. The process of descent of
IUD from womb to final expulsion can be associated with cramping increased
vaginal discharge, or uterine bleeding. However, in some cases, the only
premonitory symptom is lengthening of the IUD string thus the golden rule is to
palpate and search not only for strings but also to search or hard any plastic
mans in the neck of the womb i.e. opening of the womb (external os).
C. Incidence of accidental
pregnancy:
Fortunately, the annual incidence of accidental pregnancy decreases
steadily after the first year of IUD use. The cumulative pregnancy rate after
seven years of use of the copper T380A IUD (most common brand used in India) is
only 1.6%.
D. Complication of pregnancy while
IUD still remaining inside womb:
If she is pregnant with IUD still inside then there will be an increases
risk of spontaneous abortion. If the
IUD is not removed then the incidence of spontaneous abortion which is
approximately 55%, or roughly three times greater than would occur in pregnancies
without an IUD. More than half of the spontaneous abortions in IUD users occur
in the second trimester. However, if the IUD is removed right after conception
than the risk of abortion is close to average abortion rate (about 20%). For
some reason or other the gestational period between 14-24 weeks is dangerous
(if the IUD is not removed) because severe infection (sepsis) may occur. The genital sepsis can be fatal and hence
once pregnancy is diagnosed, IUD should always be removed.
E. Client wishes to continue
pregnancy - What to do?
If a woman using the IUD becomes pregnant and wishes to continue the
pregnancy then IUD should be removed at the earliest to avoid increased risk of
spontaneous abortion. These will also obviate the increased risk of septic abortion in the second trimester
and increased risk of premature delivery.
There is no evidence that the IUD in a pregnant woman increases the risk for
birth defects in the foetos.
F. The client does not wish to
continue pregnancy:
She should be advised to undergo surgical termination of pregnancy
preceded by removal IUD. Medical
abortion i.e. abortion by drugs is not recommended while IUD is still inside
the womb. However, abortion by drugs can be carried out after removal of
the device. The following procedure should be adopted if a woman using IUC is
having delay in starting period. Firstly she should palpate for strings.
Secondly, urine for pregnancy test is to be contemplated. If the urine test is
negative she can repeat the test after ten days. If this test is also negative
she can take tablet Orgamed (10), one tablet for ten days which will help
menstrual bleeding and allay her anxieties. This natural delay in period is
most commonly due to breastfeeding. If urine test is positive then one should
exclude possibility of ectopic pregnancy i.e. pregnancy occuing outside womb.
This can be done by serial blood testing for βhCG hormone and ultrasonography.
In addition gynecologist’s advice is a must.
The
concerned HCP should alert the acceptor that if the device is not removed as
soon as pregnancy is diagnosed then she is at risk of second trimester miscarriage, pre-term delivery and above
all severe infection of womb if the
IUD is left in place IUD removal is mandatory and the removal of the IUD
reduces these risks, although the procedure itself entails a small risk of
miscarriage. After removal of IUD she can continue the pregnancy if she so
wishes but there will be always some risk of miscarriage, preterm delivery. If
she opts to continue pregnancy she should be advised to seek medical care
promptly if she has heavy bleeding, cramping, pain, abnormal vaginal discharge
or fever. If she does not want to continue the pregnancy, surgical termination
of pregnancy may be contemplated along with removal of the device.
Ectopic Pregnancy (Pregnancy occurring outside the womb i.e. in the egg-transport tube).
Any
pregnancy in an IUD user, inside or outside womb is uncommon and thus IUD users are 50% less likely to have an
ectopic pregnancy when compared with women using no contraception. It is
well known that infection of fallopian tube (P.I.D.) can favor ectopic
pregnancy at a later date. Earlier, medical fraternity used to believe that IUD
promotes pelvic sepsis including infection of fallopian tubes. HCP many believe
that IUD may promote ectopic pregnancy at a greater rate than usual population.
But that is not true. It has been proved now that IUD does not provoke pelvic
infection if cases are properly selected (clients without risk of STD). Sadly,
the bad reputation of IUDs regarding increased incidences of PID and increased
rate of ectopic pregnancy (EP) still prevails not only in the minds of common
people, but also amongst doctors.
The
rate of ectopic pregnancy in the general population vary depending on
sociocultural and sexual behavior of the men and women of the locality. The
estimated ectopic pregnancy rate among sexually active women using no method of
contraception has been estimated to be between 3.25 and 8.0 per 1000 woman
years. Contrary to popular belief the incidence of ectopic pregnancy among IUD
users is between 0.125 and 4.0 per 1,000 women years of IUD use.
If
we consider the ratio of ectopic pregnancies, to total accidental pregnancies
while still wearing copper IUDs it is seen that rate of EP is 39 per 1000 total
pregnancies. This is almost similar to the ratio of 43 per 1000 pregnancies
while not on contraceptives. From this stand point it may be inferred that if a
woman becomes pregnant with IUD in place, her risk of ectopic pregnancy is
increased compared with the overall population of pregnant women. In fact,
protection against all tubes of pregnancies provided by both Tcu-380A is so
great that WHO has put these devices as category 1 (i.e. safe to use) even in women with previous ectopic
pregnancies.
Though
the incidence of ectopic is very low still it will be prudent to warn the women
using IUDs about the features of ectopic pregnancy. They should be informed
about common symptoms of EP e.g. abdominal pain, ‘dark and scanty’ or ‘inter
menstrual bleeding’ along with the usual signs of pregnancy. The women
concerned should visit HCP urgently if these symptoms appear. Another note of
caution. If an IUD user conceives, health care provider should always look for
ectopic pregnancy by sonography and serial blood tests for beta-hCG hormone.
In
summary it may be said that IUD users are statistically less protected against
ectopic pregnancy than users of other contraceptive methods. One should
remember that IUD does not prevent ovulation and possibly does not impede
fertilization. IUD prevents nidation by primarily altering the inner
environment of womb. Thus IUDs protect intrauterine pregnancy more effectively
than extra uterine pregnancies.
Newer Copper IUDs:
Researchers
continue to develop and test new IUDs that may reduce expulsion rates and other
side effects. Among the devices being that has become successful is CU-SAFE
300. It is smaller, lightweight, and flexible T-shaped copper IUD which can be
inserted without a plunger and is designed to move towards the uterine fundus
(the top of the uterus) when the uterus contracts. Additionally another new
device is getting fast popularity i.e. frameless IUD consisting of six copper
sleeves on a surgical nylon thread. It is also Flexi Gard 330, or Cu Fix PP
330. The thread is knotted at one end, which is anchored in the muscle of the
fundus. In clnical trials the device has proved to be highly effective and
comfortable to use. A Copper bearing IUD with a T-Shaped frame, called the Sof-T
is becoming popular at smiliserlad. In thus new device. The tip of each end of
the arm consists of a soft ball, designed to prevent perforation and to block
the openings to the fallopian tubes in order to prevent sperm from entering.
The
very purpose of these new devices is to reduce pain and irregular bleeding
associated with in the existing copper beeaing IUDs including the most popular
type i.e. T-Cu-380A. Earlier the plastic frame where of different shapes e.g.
coil, ‘s’ shaped, circular, triangular or elliptical. Now the only shape
recommended is ‘T’ shaped because the cavity of womb is like ‘T’ which fits
well with geometric of uterus and adaptation inside the womb is satisfactory if
the plastic is of some other type then the frame will hinge the inner wall of
womb and cause uterine camps and possibly bleeding.
Additionally the very plastic used is
now made up of more flexible material. We are aware of the fact that womb
contracts and relaxes spontaneously at varying intervals without the knowledge
of a woman. If a ‘rigid’ plastic frame is used then it will not yield or bend
to accommodate the shape of the contracted womb. So a rigid plastic frame is
bovend to cause cramps and bleeding irregularities. However new copper IUDs
discussed below are not approved for use in all countries. Till date the
developers and manufactures report fewer expulsions, higher continuation rates,
lower failure rates and easy insertion-removal as main advantages of all these
new copper IUDs.
Chapter XII ABC BOOK (Contraceptives for sick women)
Role of POP in women with high blood pressure:
Women
with high blood pressure are prone to have ‘heart attack’ or ‘cerebral stroke’
i.e. bleeding from arteries inside brain matter or clotting of blood in venis
inside the brain substance. It is said that hormonal contraceptives by changing
coagulation system in the body and by altering fat metabolism adversely promote
these fetal accidents. Thus one should
try to avoid hormonal contraceptives in hypertensive women. But it is equally
true that the hormonal contraceptive and IUD (Intrauterine Device) are the two
most reliable temporary methods of contraception. The existing other temporary
methods are not so much effective. Therefore, if one options for effective
temporary method the option will be either IUD or hormonal methods. But many
Indian women do suffer from variety of gynecological diseases where use of IUD
is contraindicated. In them one has no other option but toprescribe hormonal
contraceptives even if her blood pressure is slightly raised. Thus one has to
make a balance between efficacy and risk of contraceptive use in women with
high blood pressure.
POP,
though a hormonal contraceptive but the hormone is used in very low dose. So
POP is reasonably safe to prescribe in women with mild to moderate hypertension
even if she is on antihypertensive (i.e. drugs to check high blood pressure).
To initiate POP the upper level of blood pressure (systolic) should be ideally
less than 159 mm of mercury and the lower limit of blood pressure (i.e.
diastolic) should be below 99 mm o mercury. These readings may be with or
without blood pressure reducing drugs. But POP is not usually prescribed in
women if blood pressure is above 160 systolic and or above 100 mm of mercury
diastolic (WHO category 2 women for POP usage). That is only in special
circumstances particularly when more
appropriate methods are not available acceptable to the couple then only
POP may be used in such women. The HCP need to assess the severity of her
circulatory system and whether the woman will come regularly for follow up.
Conceivably, these women mandate frequent three monthly follow up of POP is at
all used.
It
may be recalled that traditional COCs are very risky (category 3) in women with
such high blood pressure. Copper bearing IUDs are the safest the temporary
contraceptive method for hypertensives and diabetics too. The other options are
POP Mirena IUS (Hormonal IUD). Though women with slight elevation of blood
pressure may use hormonal IUS but if hypertensive is severe (blood pressure
> 160/100) then she should not use LNG-IUS.
RISK SATISFACTION OF
HYPERSENSIVE WOMEN
|
|
Mild hypertension
BP < 140-159/90-99
|
Severe hypertensive
(> 160/100)
|
|
|
Barrier
|
1
|
1
|
|
|
LAM
|
1
|
1
|
|
|
COC
|
3
|
4
|
|
|
POP
|
1
|
2
|
|
|
Quarterly
Shots
|
2
|
3
|
|
|
Implants
(Implanon)
|
1
|
2
|
|
|
Combined
monthly Injection
|
3
|
4
|
|
|
Copper
containing IUD
|
1
|
1
|
|
|
Hormone
releasing IUS
|
1
|
2
|
|
History high BP in pregnancy but
current level is normal – COC is category 2 risk but POP and Quarterly Shot may
be used.
Safety POP in Diabetes: (high blood sugar):
In
recent times prevalence of diabetes and high blood pressure has gone up in
India. What about use of POP in diabetics? Is POP safe? The following is the
guideline.
4)
Those
who had temporary rise of blood sugar during pregnancy (gestational diabetes
mellitus) they can safely use POP. Alternatively, they can also use COC with no
added risk (zero risk or category I women for COC usage). In fact all methods
are safe for women who had such temporary rise of blood sugar.
5)
Those
with established diabetes but sugar is within control, they can also use POP or
COC provided there is already no change in the blood vessels as evidenced by
eye (retinal) examination. Even those who are using insulin can use COC or POP
provided diabetes is well controlled and there is no associated vascular
disease. However, these two hormonal contraceptives i.e. POP and COC are
contraindicated if diabetes is not well controlled.
6)
Those
diabetics who had already some retinal changes (vascular changes in the eye ball
as evidenced by simple clinical examination by ophthalmoscope, Kidney changes
or nerve changes they too can use POP (category 2 risk). COC will be more risky
in such women (category 3 risk). In fact all methods except copper bearing IUDs
are category 2 risk for women with established diabetes mellitus. It is
needless to mention that barrier contraceptive and natural family planning
methods fertility Awareness method) are safe options but efficacy of these are
limited. Use of spermicides in uncontrolled diabetics may invite severe pelvic
infection and thus not recommended.
POP in HIV and contraceptive choices for HIV Women:
Women
account for nearly half of the estimated 40million cases of HIV infection
worldwide. In 2006 on estimated 17.7 million women ages 15 and older, or about
13 in every 1,000 such women, were infected-approximately one million more than
in 2004.
Like
all other women, women with HIV have the right to make their own decisions
about their reproduction and sexual health.
Women
with HIV face many decisions about living with HIV. Decisions about sex and
childbearing can be among the most important. She may also need to ask her
partner if he knows his HIV status and, if not, encourage him to seek HIV
testing.
Preventing
unwanted pregnancy is a key element
in the four-element strategy for preventing mother-to-child transmission of
HIV. As indentified by the UN in the Glion Call to Action on Family Planning
and HIV/AIDS in Women and Children, the four elements respond to health care
providers’ four opportunities to reduce mother-to-child transmission. The Glion
Call to Action states that all four elements are essential for meeting the UN
goal of halving the proportion of infants infected with HIV by 2010.
All hormonal methods appear to be safe for
women with HIV. Theoretically, certain antiretroviral (ARV) medications could
reduce the effectiveness of low-dose hormonal methods, but
CHAPTER –
V(Final)
Intrauterine
System---Hormone bearing IUDs
Overview:
Intrauterine
contraceptive devices or IUDs are materials which when introduced inside the
womb (uterus) exert contraceptive effect usually 3-12 years depending upon the
material with which the device prepared. Intrauterine contraceptive device of
‘first generation’ were made only of plastic material. These were called insert
IUDs or plastic IUDs. Unlike present day copper releasing IUDs there first
generation IUD did not contain only active metal or hormonal agent which could
exert added contraceptive efficacy. There insert IUDs exerted their contraceptive
efficacy mainly by mechanical limitation inside womb. None these less these
IUDs were popular in the decodes of sixties and early seventies but due to
their poor contraceptive efficacy and increased side effects (bleeding and
pelvic pain) these insert IUD ere replaces by copper containing IUDs which soon because popular. There are called
second generation IUDs. In fact
copper containing IUDs which was introduced the late seventies are still the
most popular IUD.
There
are some women who are unsuitable for copper containing IUDs. These women
usually have some gynaecological complaints or disease e.g. menorrhogia, small
myoma (tumors of womb) or endrometrioss etc). Such women will be benefited by
fitting with an IUD which contain progesterone hormone. These progesterone are called first generation IUDs. The
progesterone hormone used in the device is Levonorgestrel
the abbreviation of which LNG and
the contraceptive device is called ‘LNG-IUS’.
In
view of the fact that such hormone containing IUDs release progesterone inside
the womb these devices will take care of existing gynecological disease in
addition exerting contraceptive action. Thus women suffering from above quoted
gynaecological diseases will achieve dual benefit of ‘disease control’ as well as ‘contraception’
by the use of ‘LNG IUS’. But readers
should not be impression that these IUS
are meant for contraception of diseased women only. LNG IUS device can
certainly be used in healthy women too particularly where copper containing
devices are not chosen by the acceptor.
Composition:
Like
copper bearing IUDs the frame of IUS device is also made of a light, T-Shaped
plastic frame with the stem for the T a bit thicker than IUDs. It is stem which
contains a tiny storage system of contraceptive hormone levonorgestrel. The device is 32 mm in length and 4.8 mm in
diameter. Like copper being devices it is also impregnated with barium sulphate
which makes it radio-opaque. So that device became visible by ordinary X-Ray.
In
fact the hormone reservoir designed as a sleeve of 52mg of levonorgestrel mixed
with polydimethyl siloxane elastomer (see fig). This sleeve in turn surrounds
the vertical stem and is covered on its outer asfeet by a membrane, which
regulates the intrauterine release of progesterone hormone from reservoir.
There is release of 20 mcg per 24 hours with passage of time. The release rate
slowly decreases to about 15 mcg per day with the fifth year of use and to
about 12 mcg per day at the end 7 years.
Brand Name:
The
levonorgestrel-releasing intrauterine system (LNG-IUS) ‘Mirena’ or ‘Levo Nova’. This device was approved in the country of
origin, Finland, in 1990 FDA of US issued its approval in the year 2000. It is
manufactured by Leiras OY (Turku, Finland), and it is currently on the market
for contraceptive use in 88 countries including India. In some country have, it
is viewed chiefly for treatment of
menorrhagia and as progestin component in postmenopausal hormone replacement therapy.
Mode of Action:
1)
Progesterone
hormone released from the device impains upward migration of sperm by
increasing cervical mucus viscosity.
2)
Progesterone
also cause damage to sperms by causing changes in enzyme present in the womb
which facilitates sperm transport from womb to egg-carrying tubes (fallopian
tubes).
3)
Additionally
LNG-IUS acts locally on the endometrium (inner lining of womb) and cause
profound changes the future bed of embryo so that fertilized ova cannot get
embedded. Thus in case occasionally union between sperm and ova occur in the
usual site i.e. egg carrying tube (fallopian tube). When fertilized ova arrived
at womb for nidation or (implantation) it foces adverse environment in womb and
unable to get embedded.
In summary LNG-IUS either immboliges
sperms or inhibits sperm changes necessary for fertilization. It is not an
abortificient even if one considers life beings as soon as fertilization
occurs.
Unlike oral pills IUS does not alter
ovarian function. Because the amount of progesterone absorbed from womb is
minimal too modify normal functioning of ovaries. In fact blood level of
progesterone is well below 50% of minipill.
Intrauterine Dwelling Time Duration of Efficacy:
The
device is currently approved for a period of five years and removal should
follow thereafter. If a woman desire to continue contraceptive use, the device
can be replaced after stipulated five years and a new one fitted immediately
after removal of the used device. But recently evidence is fast accumulating
that LNG-IUS retains its contraceptive efficacy for seven years. Many trials
have affirmed such claim.
There is evidence that the copper T 380A the
most popular brand of IUD has an effective life span of at least 12 years,
during which time the pregnancy rate remains very low.
Contraceptive Efficacy:
LNG-IUS
(Mirena a Leva Nova) is a highly
effective long-acting, reversible contraceptive associated with a cumulative
gross pregnancy rate of 0.0 to 0.5 for 4 or 5 years or with a pearl index (See
Page ) of 0.0 to 0.2 for 7 years. In
fact it is so effective contraceptive that it is aptly called ‘reversible sterilization’.
STD Prevention:
Unlike
male or female condom it does not offer great protection against STI.
Nevertheless LNG-IUS makes cervical mucus thick and viscid. Thus it offers some
resistance to upward progress of organisms responsible for sexually transmitted
infection (STI). As it does not completely elements the possibility of
acquiring STI. Therefore women who are at risk of STI should be advised to use
barrier contraceptive in addition (dual protection).
Advantage as Contraceptives:
1)
Highly effective: Failure
rate of only 0-2 per 100 women years.
2) Minimal hormone related systemic side effects: The
hormone used in LNG-IUS is also used in most contraceptive pills including
minipills, and subdermal impalants (implanon).
In IUS however, a much lower does is released is body than when one takes
contraceptive pills. Further in case of IUS the hormone is deposited directly
in the lining of the womb, rather than in the blood stream. Hence progesterone
related side effects are less common with IUS.
3) Makes quality of life better in selected women: LNG-IUS
has a definite edge over copper IUDs as it does away with a number of problems
associated with conventional IUDs. For instance LNG-IUS causes light and less
painful periods instead of excessive and painful periods as with copper
containing devices. It also reduces the amount and duration of monthly period.
4) Does not alter the ovarian function and other natural hormones of body: The
normal ovarian functions are not disturbed neither the ovulation process is
suppressed. This is because during use of the LNG-IUS release of progesterone
(Levonorgestrel) is limited to 20mcg 24 hours amount yield to a of progesterone
well plasma levels below 0.2mg/ml. The level i.e. minimally required suppress
ovulation.
In short LNG-IUS is a
reversible method and unrelated to sexual: The best features of this system is its high
contraceptive efficacy, reduction in MBL (menstrual blood loss), protection
against ascending pelvic infection,a nd minimal interference with ovarian
function.
Limitations of contraceptives:
1)
High Cost:
It is good contraceptive for women of developing world
because the main non contraceptive benefit of LNG-IUS is decrease in menstrual
blood loss. This makes it as the best choice in women with anemia. It is well known that both nutritional anemia
and iron deficiency anemia are prevalent in women of developing countries. But
unfortunately, women of resource poor countries cannot afford to high cost
(Rupees six thousands in Indian currency to purchase LNG-IUS contraceptive.
2)
Irregular bleeding:
The other disadvantage is irregular intermenstrual
bleeding or amenorrhoea, neither of which are acceptable in some cultures.
Nevertheless continued use of the device greatly diminishes menstrual
irregularity. But to achieve this she has to use it at least for six to eight
months. Thus the first 4-6 months is crucial and great patience is to be
exercised. Continuation for first six months depends chiefly on attitude of the
client as well as on good counseling before and after the IUS is fitted.
3)
Must be fitted by a trained doctor:
Unlike copper IUDs this specially designed IUS cannot
be inserted by nurses or paramedical personnel. This is simply because the stem
of vertical limb of the device is much thicker than most copper containing
IUDs. So in most cases insertion will require some dilatation of cervix
preferably under short anesthesia. Thus fitting of IUS is technically a bit
difficult and only skilled persons can fit the device properly.
4)
Spontaneous expulsion:
This is rarely possible. In such an unfortunate the
women gets disappointed. She incurs some financial loss too.
5)
Mal position of IUS:
Through rare but this can occur either during the
insertion process or subsequently. It is noteworthy that all IUDs and IUS are
susceptible to undergo axial rotation while still remaining inside the womb.
This happens due to normal contraception and relaxation of the musculature of
womb.
6)
Not all women are suitable for IUS:
Role of Pre insertion hysteroscopic evaluation:
There are some women who has some disease of womb e.g.
inside partition, small tumors or polyps abuting the inner cavity of womb. They
are unsuitable for any intrauterine device. If LNG-IUS is fitted without
assessing cavity of womb then there remains faint possibility of having
persistently annoying side effects which may last for months together such an
event will impede the rising popularity of this IUS. To put in other way not
all women are fit for IUS and a pre-insertion evaluation by putting a small
endoscope inside the womb to access the inner walls or cavity of womb is
desirable though not essential. In fact
hystroscopic agreement is seldom practised and this practice is possibly
limited to skeptic doctors only.
7)
Unlike
copper bearing IUDs, LNG-IUS cannot be used as postcoital emergency contraception.
8)
Pregnancy
can follow if the device is expelled spontaneously without the knowledge of the
acceptor. This is again a rare event. In summary, though the LNG-IUS may not
replace copper intrauterine devices due to its above quoted limitations and
high costs, it could certainly be used as a selective contraceptive method for women who would benefit from it.
Non Contraceptive Benefits:
1)
Makes
periods lighter from. Most copper IUDs make a woman’s periods heavier, By
contrast the LNG-IUS makes periods lighter than usual. As a matter of fact
there may be reduction of blood loss up to 94% after 3 months of use and after
12 months reduction may be up to 96%. Many clients won’t believe this! Because
of this, it is frequently used as a treatment for heavy periods, even in women
who don’t need contraception.
2) Helpful in many gynecological disease: LNG-IUS
ameliorates many gynecological diseases notably memorhagia, (excessive flow
either in amount or duration), dysmenorrhoea (painful periods), endometriosis
(collection of menstrual blood in the tummy) and myom (a common begin tumor of
womb).
3)
Improves
premenstrual syndrome often called PMS.
4)
Reduction of pelvic infection: The
device appears to be protective against pelvic inflammatory disease (PID)
because of thickening effect on cervical mucus thus preventing ascending
infection. The incidence of pelvic infants disease (PID) with LNG-IUS was found
to be 0.8 per 100 woman years as compared to 2.2 with copper IUD.
Ideal Candidate:
IUS
is most appropriate contraceptive method for women with menorrhagia (excessive
menstrual bleeding) or who prone to have to iron deficiency anemia. It is also
suitable for women who are candidates of thalassaemia or sickle cell disease.
It is also suitable for women suffering for dysmenorrhoea and or endometriosis.
It is an ideal contraceptive who are candidates with bleeding disorders or an
anticoagulation therapy. Breastfeeding women after 4-6 weeks postpartum can use
it similarly it can be used in women who are mentally retanded as a long term
contraceptive. It is safe for epileptics too. In short it is ideal for women
who are mother of one or two children and seek long term contraception but
there should not be any anatomical abnormality of womb i.e. cavity distortion.
Side effects and managing the problems:
I.
Menstrual Bleeding Disorders: After
insertion of the LNG-IUS there is often a period of frequent irregular bleeding
or spotting during the first 2-3 months. This bleeding although small in
quantity may be very frequent or continuous in some women. These episodes can
cause considerable discomfort and inconvenience particularly to working women.
Interestingly though during first two to four months the number of
bleeding/spotting days are increased but the total volume of blood loss is
reduced compared with the woman’s normal menstruation. However if the woman is
dissatisfied with bleeding pattern then it can be managed by prescribing mefamic acid tablets (e.g. meftal tablet
500mg) 1 tab twice daily for 5 days.
She should be counseled that with increasing duration of use she will
develop amenorrhea. The rate of amenorrhea towards the end of the 5 year period
of use is around 25 percent. This is of considerable advantage to women who are
already anemic. Reassuringly the menstruation returns in these amenorrhoeic
women within 30 days of removal of IUS.
II.
Progesterone related side effects:
Progesterone induced side effects/bloatedness e.g. Breast tenderness,
headache, acne and occasionally depression may occur. These symptoms occur only
in few women and pass off as the release rate of progesterone from IUS
decreases. 3) Spontaneous expulsion of the device. In such an event the women
will be unable to feel the thread in the upper part of vagina. 4) Partial
expulsion of the device is also rare. This should be suspected if the women
complain that she is feeling something hard in the mouth of womb (cervix) or in
the upper part of vagina. This may be associated with pain and cramping. On
examination HCP can visualize the lower part of the vertical limb of the device
in the cervix. Normally no part of the device should be visible. Only the
strings should be thus visible. Thus lengthing of the strings or visualization
of part of the device are indications that the device has come down and is going
to expel in no time. In such situation the device should be removed and a new
one fitted.
Wearing Signs:
1)
Persistent irregular bleeding with
pelvic pain: This may mean ‘disturbed uterine pregnancy’ while IUS still remaining inside or it
may be due to ectopic pregnancy (0.02
per 100 woman years.).
2) Pelvic pain alone: This may be due to pregnancy
occurring in fallopian tube (egg transport tube) torsion of small cyst of ovary
or acute P.I.D. (pelvic inflammatory disease). Thought 10-12% of IUS users
exhibit sonographic evidence of cyst formation but torsion of such small cyst
is very rare (1:2000).
3)
Fever and pelvic Pain: This
may be due to pelvic inflammatory disease or acquiring fresh STI.
Contraindication:
Absolute
contra-indications are a) known or suspected pregnancy, b) current on recurrent
pelvic inflammatory disease, c) lower
genital tract infections particularly mucopurullent cervicities. d) postpartum
or postabortal endometritis i.e. infection of the womb. e) cervical dysplaria
f) known or suspected carcinoma breast g) uterine or cervical malignancy h)
leukaemia, i) valcular diseases of heart j) severe arterial disease.
Additionally
women with known disease of uterus where cavity
distortion has been substantiated by previous investigations (sonography or
hystrography or hystrocopy) then such women should be considered as unsuitable
for both IUD and IUS.
Relative
contra-indications are history of previous ectopic pregnancy, thromboembolic
disease, history of ovarian cyst. Unlike copper bearing devices LNG-IUS cannot
be used as emergency contraceptive.
Health Risks:
1)
Pregnancy occurring all side the
womb: The absolute
ectopic pregnancy rate is extremely low with LNG-IUS. The ectopic pregnancy
rate of 0.02 per 10 woman years can be compared very favourably with copper T
users (0.25 per woman years) and sexually active women not using any
contraception (1.2-1.6 per woman years). Nevertheless as LNG-IUS is so
effective in preventing intrauterine pregnancy, if a pregnancy does occur with
the IUS still remaining in womb then there is a high suspicion of being
ectopic. The client should be forewarned about this very rare possibility
whenever period is missed and home monitoring of UPT (Urine for pregnancy test)
is positive.
2) Performation of womb: Occassionally performation of
womb can occur particularly when IUS is fitted in early postpartum period
when uterus is soft. Like copper IUD performation can be confirmed by
sonography and will necessiatate laporoscopic removal of the device under
general nesthesia.
3)
Risk caused by systemic absorption of progesterone. The blood level while
wearing LNG IUS is 50% less than when women use minipill. Thus of all the
hormonal contraceptives adds minimum hormonal level in LNG-IUS blow this
minimizes the risk to her health. It is very unlikely that such minimal
increase of progesterone hormone in blood will exhibit any adeverse effect on
lipid profile or cause arterial changes.
Timing of insertion of IUS:
1)
In
regularly menstruating women IUS can be fitted within first six days of
commencement of menstrual period. No back up is needed. If IUS is fitted seven
days after commencement of period then barrier contraceptive should be
advocated for next seven days thus that allowing sufficient time to exert its
full contraceptive effect. However insertion may be planned at any other day of
cycle if there is no sexual intercourse in that cycle.
2)
Six
weeks after normal childbirth and four weeks after induced or spontaneous
abortion if there is no clinical evidence of sepsis. Some people however have
suggested fitting LNG-IUS as early as seven days after an abortion procedure as
soon abortion induced pain and bleeding pass off.
3)
Insertion
during lactational ammenohea has been after performed, with great satisfaction
of acceptor. It can be done as early as 6 weeks but often carried out 8 weeks
after normal childbirth. The use of sounding however is contraindicated during
such puerperal insertions because musculature of womb is still soft and may
cause perforation of womb. The acceptor may be unnecessarily worried about
health of child but the daily amount of LNG excreted in 600ml of breast milk is
approximately 0.1% of the intrauterine daily dose. Thus there is interference in
the development of the newborn.
Follow Up:
First
follow up visit may be planned one week after insertion and later on monthly
basis for first three months. Other after unless there is any complaint no
routine follow up is recommended but she should continue to feel the thread
after each menstrual period and be satisfied that the device has not silent
fallen off the womb.
The
idea of first follow up arranging so soon is to discuss with the woman about
bleeding symptoms and if there be any pelvic pain. Additionally she should be
encouraged to bear the inconvenient of bleeding for couple of days. These
simple encouraging words or even telephonic advice will boost up the moral of
client to continue the device in spite of minor sick effects or discomfort.
At
follon up visits she should be enquired about any pelvic pain which may imply
either descent of the device or malrotation of the device while still remaining
in womb to achieve near 95% continuous rate the caregiver should offer ample
opportunity to discuss her concerns about IUS. The staff should be caring,
helpful and never dismissive. HCP should never cloud her doubts but should try
to clarify the unspoken concerns related to IUS. The duty of HCP is to check
her blood pressure and record weight HCP should then perform and interval
exception and be satisfied with the visible part of the length of thread though
such interval exertion is seldom required in intelligent women. However the
continuation rate LNG-IUS is 85% after the end of one year and that of copper
IUSs is 78%. At last she should be reminded that LNG-US do not prevent STI and
if she considers that there is a possibility of STI. She should insist on
barrier contraceptive in addition.
Counseling tips:
LNG-IUS
is usually very well tolerated in women who have received careful counseling
about the possibilities of irregular
bleeding for first two or three month and subquently amenorrhoea. But poorly counseled women may become concerned and
even request removal of the device. Thus before fitting IUS it is desirable
that counselor should have an unbiased
and unhurried discussion with the acceptor explain pros and cons of IUS.
Above all trust and confidence in the care givers is as important as candid
discussion on this costly contraceptive. Not only the extensive counseling but
successful use of LNG-IUS requires good training of doctors who fit the IUS. In
fact acceptance and continuation rate of any contraceptive method are dependent
on technical and counseling skills of the providers. Further, management of
side effects and due attention to complaints also are important factors for
high continuation rate poor selection of users or poor counseling result in
unnecessarily high request for removal of device.
Copper being devices Vs. LNG-IUS:
Which
device to choose? The opinion of scientists varies in this regard. The side
effects, failure rates, discontinuation rates, spontaneous expulsion rates have
been compared by different health institutions. For average women cheaper T Cu
380 is better as it has proven efficacy of long 12 years. But after though
counseling if potential acceptor is worried about persistent amenorrhoeic
induced by Copper being IUD the LNG-IUS may be a better option. No doubt women
with gynecological diseases like dysmenorrheal and endometriosis will opt for
LNG-IUS. For interested readers short comparison between the two commonly used
devices is mentioned below –
|
|
Cu T
|
LNG-IUS
|
Cu T
|
LNG-IUS
|
Cu T
|
LNG-IUS
|
|
Cost
|
1-1.4 preg per 100 w years
|
Do
|
|
|
|
|
|
Failure rate
|
8.4 per 100 users
|
11.7
|
|
|
|
|
|
Expulsion the rate
|
3.6 per 100 users
|
3.6 per 100 users
|
|
|
|
|
|
PID incidence
|
|
|
|
|
|
|
|
Discontinuation rate
|
|
|
|
|
|
|
Myths & Barriers to LNG-IUS use:
1)
There
device promote pelvic infection (P.I.D.) thus may invite infertility. In fact
IUS do not promote P.I.D.
2)
The
risk ectopic pregnancy is unacceptably high. The reality is that incidence of
ectopic pregnancy is considerably less end in LNG users than general population
not using contraception.
3)
The
device may go to inside tummy. The rate of womb perforation is very rare.
4)
The
return of fertility be unduly delayed. This is not true.
5)
It
cannot be used in nulliparous women. In fact nulliporous women can use it
though introduction i.e. fitting of IUS may be comparatives more difficult.
6)
Women
affected with HIV cannot use IUS. IUS can be used in women affected with HIV
though it is considered as category 3 risk. But IUS’ is very effective. So it
can be used to achieve near 100% prevention of pregnancy. Barrier contraception
should be used concomitantly to prevent HIV transmission.
The groing evidence suggest that barrier contraceptive as commonly used
do not prevent pregnancy all the time. That is the reason why women suffering
from STI should avail dual protection
i.e. barrier (to prevent STI) along with some effective contraceptives (to
prevent conception).
Take home message:
The
LNG-IUS was marketed in US in the year 1995. It is a highly effective
contraceptive method which can be safely used for 5-year period. The release of
levonorgestrel (LNG) hormone (progesterone) inside the womb represents a new
approach in contraceptive technology as it (hormone) exerts local action thus
avoids systemic side effects related to hormone.
The
levonorgestrel releasing intrauterine system (LNG-IUS) continuously release
progesterone hormone for at least 5-7 years tus offers an effective ‘estrogen free long-acting, reversible
contraceptive. It offers effective protection
against ectopic pregnancy and due to
its low systemic steroidal dose, any side
effects are mild and few. It can be fitted four to six weeks after
childbirth. It does not affect production if breast milk neither does it affect
growth of infant.
There
are some vices as well. The device is costly and not distributed by Govt. of
india nor subsidized by an NGO in resource poor countries.
Many
women do suffer from irregular vaginal
bleeding for first few months which may be annoying to them. But after four to
six months most will have regular periods and by one year majurity will achieve
amenorrhoea i.e. nonoccurrence of monthly periods. Inspite of all thee
nuisances LNG-IUS does not predispose to any health risk. Nevertheless LNG-IUS
remains the only option for w9omen who intend to have long term reversible
contraception (no daily commitment). The other such options are implanon
and quarters shots. Subdermal implant ‘Implanon’ which is effective for three
years are not readily available in most countries including India. Hopefully
this will be available in India by 2010.
********************************************
LNG IUS (Mirena/Leno Nova):
These
IUDs are almost same as copper bearing IUDs except that the vertical limb of
the T-shaped plastic frame is so designed that it accomodets a small cylinder
of progesterone hormone inside. This progesterone
filled cylinder continue to release small amount of progesterone daily
inside the womb for five year continuously. The levonorgestrel releasing
intrauterine system (LNG-IUS) has now become one of the most effective
contraceptive methods available. Additionally this hormonal contraceptive
primarily exert its contraceptive action by topical action on womb and there is
minimal rise of progesterone hormone in blood. Therefore, LNG-IUS has virtually
no systemic hormonal side effect. LNG-IUS thus is a hormonal contraceptive method with the lowest hormonal does to be
tolerated by a woman. The common brand names are ‘Mirena’ IUS and Levo Nova the Mirena IUS is like many other types
of Intrauterine contraceptive Devices (sometimes located IUCD’s or coils) in
that it is lay to be fited by a doctor and remains in the womb for a fixed
amount of time, after which it must be changed. It is different, however, in
that it is much more effective than usual IUD’s and avoids many of the side
effects of copper containing IUDs.
LNG-IUS
exerts contraceptive effect at least for five years. Nevertheless it continues
to release small amount of progesterone in the fifth and sixth year at a
smaller dose i.e. at the rate of 14mcg/day. Even this small dose is sufficient
to effects contraception. After seven years, however, the contraceptive
efficacy falls markedly. Therefore many scientists now recommended that LNG IUS
is effective for seven years. In fact people have tried for seven years and
they are satisfied with its contraceptive efficacy in last two years also.
***********************************************************
Extract
from the Book published on contraceptives:--Dr Srimanta Pal ( (File Name:
C:\Users\Dr.Srimanta Pal\Desktop\All 13 Folders on Books_07_09_2010\1) ABC OF
CONTRACEPTIVES\Chapter III - Intrauterine Devices Part – II.docx)
CHAPTER – III (Part – II)
Intrauterine System---Hormone bearing IUDs
Overview:
Intrauterine contraceptive devices or IUDs
are materials which when introduced inside the womb (uterus) exert
contraceptive effect usually 3-12 years depending upon the material with which
the device prepared. Intrauterine contraceptive device of ‘first generation’
were made only of plastic material. These were called insert IUDs or plastic
IUDs. Unlike present day copper releasing IUDs there first generation IUD did
not contain only active metal or hormonal agent which could exert added
contraceptive efficacy. There insert IUDs exerted their contraceptive efficacy
mainly by mechanical limitation inside womb. None these less these IUDs were
popular in the decodes of sixties and early seventies but due to their poor
contraceptive efficacy and increased side effects (bleeding and pelvic pain)
these insert IUD ere replaces by copper
containing IUDs which soon because popular. There are called second generation IUDs. In fact copper
containing IUDs which was introduced the late seventies are still the most
popular IUD.
There are some women who are unsuitable for
copper containing IUDs. These women usually have some gynaecological complaints
or disease e.g. menorrhogia, small myoma (tumors of womb) or endrometrioss
etc). Such women will be benefited by fitting with an IUD which contain
progesterone hormone. These progesterone
are called first generation IUDs. The progesterone hormone used in the
device is Levonorgestrel the
abbreviation of which LNG and the
contraceptive device is called ‘LNG-IUS’.
In view of the fact that such hormone
containing IUDs release progesterone inside the womb these devices will take
care of existing gynecological disease in addition exerting contraceptive
action. Thus women suffering from above quoted gynaecological diseases will
achieve dual benefit of ‘disease control’
as well as ‘contraception’ by the use
of ‘LNG IUS’. But readers should not
be impression that these IUS are meant
for contraception of diseased women only. LNG IUS device can certainly be used
in healthy women too particularly where copper containing devices are not
chosen by the acceptor.
Composition:
Like copper bearing IUDs the frame of IUS
device is also made of a light, T-Shaped plastic frame with the stem for the T
a bit thicker than IUDs. It is stem which contains a tiny storage system of
contraceptive hormone levonorgestrel.
The device is 32 mm in length and 4.8 mm in diameter. Like copper being devices
it is also impregnated with barium sulphate which makes it radio-opaque. So
that device became visible by ordinary X-Ray.
In fact the hormone reservoir designed as a
sleeve of 52mg of levonorgestrel mixed with polydimethyl siloxane elastomer
(see fig). This sleeve in turn surrounds the vertical stem and is covered on
its outer asfeet by a membrane, which regulates the intrauterine release of
progesterone hormone from reservoir. There is release of 20 mcg per 24 hours
with passage of time. The release rate slowly decreases to about 15 mcg per day
with the fifth year of use and to about 12 mcg per day at the end 7 years.
Brand Name:
The levonorgestrel-releasing intrauterine
system (LNG-IUS) ‘Mirena’ or ‘Levo Nova’.
This device was approved in the country of origin, Finland, in 1990 FDA of US
issued its approval in the year 2000. It is manufactured by Leiras OY (Turku,
Finland), and it is currently on the market for contraceptive use in 88
countries including India. In some country have, it is viewed chiefly for treatment of menorrhagia and as
progestin component in postmenopausal
hormone replacement therapy.
Mode of Action:
4)
Progesterone hormone released from the
device impains upward migration of sperm by increasing cervical mucus
viscosity.
5)
Progesterone also cause damage to sperms
by causing changes in enzyme present in the womb which facilitates sperm
transport from womb to egg-carrying tubes (fallopian tubes).
6)
Additionally LNG-IUS acts locally on the
endometrium (inner lining of womb) and cause profound changes the future bed of
embryo so that fertilized ova cannot get embedded. Thus in case occasionally
union between sperm and ova occur in the usual site i.e. egg carrying tube
(fallopian tube). When fertilized ova arrived at womb for nidation or
(implantation) it foces adverse environment in womb and unable to get embedded.
In
summary LNG-IUS either immboliges sperms or inhibits sperm changes necessary
for fertilization. It is not an abortificient even if one considers life beings
as soon as fertilization occurs.
Unlike
oral pills IUS does not alter ovarian function. Because the amount of
progesterone absorbed from womb is minimal too modify normal functioning of
ovaries. In fact blood level of progesterone is well below 50% of minipill.
Intrauterine Dwelling Time Duration
of Efficacy:
The device is currently approved for a
period of five years and removal should follow thereafter. If a woman desire to
continue contraceptive use, the device can be replaced after stipulated five
years and a new one fitted immediately after removal of the used device. But
recently evidence is fast accumulating that LNG-IUS retains its contraceptive
efficacy for seven years. Many trials have affirmed such claim.
There
is evidence that the copper T 380A the most popular brand of IUD has an
effective life span of at least 12 years, during which time the pregnancy rate
remains very low.
Contraceptive Efficacy:
LNG-IUS (Mirena
a Leva Nova) is a highly effective long-acting, reversible contraceptive
associated with a cumulative gross pregnancy rate of 0.0 to 0.5 for 4 or 5
years or with a pearl index (See Page )
of 0.0 to 0.2 for 7 years. In fact it is so effective contraceptive that it is
aptly called ‘reversible sterilization’.
STD Prevention:
Unlike male or female condom it does not
offer great protection against STI. Nevertheless LNG-IUS makes cervical mucus
thick and viscid. Thus it offers some resistance to upward progress of
organisms responsible for sexually transmitted infection (STI). As it does not
completely elements the possibility of acquiring STI. Therefore women who are
at risk of STI should be advised to use barrier contraceptive in addition (dual
protection).
Advantage as Contraceptives:
5) Highly effective: Failure rate of only 0-2 per 100 women years.
6) Minimal hormone related systemic
side effects: The
hormone used in LNG-IUS is also used in most contraceptive pills including minipills,
and subdermal impalants (implanon).
In IUS however, a much lower does is released is body than when one takes
contraceptive pills. Further in case of IUS the hormone is deposited directly
in the lining of the womb, rather than in the blood stream. Hence progesterone
related side effects are less common with IUS.
7) Makes quality of life better in
selected women: LNG-IUS
has a definite edge over copper IUDs as it does away with a number of problems
associated with conventional IUDs. For instance LNG-IUS causes light and less
painful periods instead of excessive and painful periods as with copper
containing devices. It also reduces the amount and duration of monthly period.
8) Does not alter the ovarian function
and other natural hormones of body: The normal ovarian functions are not disturbed neither the
ovulation process is suppressed. This is because during use of the LNG-IUS
release of progesterone (Levonorgestrel) is limited to 20mcg 24 hours amount
yield to a of progesterone well plasma levels below 0.2mg/ml. The level i.e.
minimally required suppress ovulation.
In
short LNG-IUS is a reversible method and unrelated to sexual:
The best features of this system is its high contraceptive efficacy, reduction
in MBL (menstrual blood loss), protection against ascending pelvic infection,a
nd minimal interference with ovarian function.
Limitations of contraceptives:
9)
High
Cost:
It is good
contraceptive for women of developing world because the main non contraceptive
benefit of LNG-IUS is decrease in menstrual blood loss. This makes it as the
best choice in women with anemia. It
is well known that both nutritional anemia and iron deficiency anemia are
prevalent in women of developing countries. But unfortunately, women of
resource poor countries cannot afford to high cost (Rupees six thousands in
Indian currency to purchase LNG-IUS contraceptive.
10)
Irregular
bleeding:
The other
disadvantage is irregular intermenstrual bleeding or amenorrhoea, neither of
which are acceptable in some cultures. Nevertheless continued use of the device
greatly diminishes menstrual irregularity. But to achieve this she has to use
it at least for six to eight months. Thus the first 4-6 months is crucial and
great patience is to be exercised. Continuation for first six months depends
chiefly on attitude of the client as well as on good counseling before and
after the IUS is fitted.
11)
Must
be fitted by a trained doctor:
Unlike copper
IUDs this specially designed IUS cannot be inserted by nurses or paramedical
personnel. This is simply because the stem of vertical limb of the device is
much thicker than most copper containing IUDs. So in most cases insertion will
require some dilatation of cervix preferably under short anesthesia. Thus
fitting of IUS is technically a bit difficult and only skilled persons can fit
the device properly.
12)
Spontaneous
expulsion:
This is rarely
possible. In such an unfortunate the women gets disappointed. She incurs some
financial loss too.
13)
Mal
position of IUS:
Through rare but
this can occur either during the insertion process or subsequently. It is
noteworthy that all IUDs and IUS are susceptible to undergo axial rotation
while still remaining inside the womb. This happens due to normal contraception
and relaxation of the musculature of womb.
14)
Not
all women are suitable for IUS: Role of Pre insertion hysteroscopic evaluation:
There are some
women who has some disease of womb e.g. inside partition, small tumors or
polyps abuting the inner cavity of womb. They are unsuitable for any
intrauterine device. If LNG-IUS is fitted without assessing cavity of womb then
there remains faint possibility of having persistently annoying side effects
which may last for months together such an event will impede the rising
popularity of this IUS. To put in other way not all women are fit for IUS and a
pre-insertion evaluation by putting a small endoscope inside the womb to access
the inner walls or cavity of womb is desirable though not essential. In fact hystroscopic agreement is seldom
practised and this practice is possibly limited to skeptic doctors only.
15)
Unlike copper bearing IUDs, LNG-IUS
cannot be used as postcoital emergency contraception.
16)
Pregnancy can follow if the device is
expelled spontaneously without the knowledge of the acceptor. This is again a
rare event. In summary, though the LNG-IUS may not replace copper intrauterine
devices due to its above quoted limitations and high costs, it could certainly
be used as a selective contraceptive
method for women who would benefit from it.
Non Contraceptive Benefits:
5)
Makes periods lighter from. Most copper
IUDs make a woman’s periods heavier, By contrast the LNG-IUS makes periods
lighter than usual. As a matter of fact there may be reduction of blood loss up
to 94% after 3 months of use and after 12 months reduction may be up to 96%.
Many clients won’t believe this! Because of this, it is frequently used as a
treatment for heavy periods, even in women who don’t need contraception.
6) Helpful in many gynecological
disease: LNG-IUS
ameliorates many gynecological diseases notably memorhagia, (excessive flow
either in amount or duration), dysmenorrhoea (painful periods), endometriosis
(collection of menstrual blood in the tummy) and myom (a common begin tumor of
womb).
7)
Improves premenstrual syndrome often
called PMS.
8) Reduction of pelvic infection: The device appears to be protective against
pelvic inflammatory disease (PID) because of thickening effect on cervical
mucus thus preventing ascending infection. The incidence of pelvic infants
disease (PID) with LNG-IUS was found to be 0.8 per 100 woman years as compared
to 2.2 with copper IUD.
Ideal Candidate:
IUS is most appropriate contraceptive method
for women with menorrhagia (excessive menstrual bleeding) or who prone to have
to iron deficiency anemia. It is also suitable for women who are candidates of
thalassaemia or sickle cell disease. It is also suitable for women suffering
for dysmenorrhoea and or endometriosis. It is an ideal contraceptive who are
candidates with bleeding disorders or an anticoagulation therapy. Breastfeeding
women after 4-6 weeks postpartum can use it similarly it can be used in women
who are mentally retanded as a long term contraceptive. It is safe for
epileptics too. In short it is ideal for women who are mother of one or two
children and seek long term contraception but there should not be any
anatomical abnormality of womb i.e. cavity distortion.
Side effects and managing the
problems:
III. Menstrual Bleeding Disorders: After insertion of the LNG-IUS there is often
a period of frequent irregular bleeding or spotting during the first 2-3
months. This bleeding although small in quantity may be very frequent or
continuous in some women. These episodes can cause considerable discomfort and
inconvenience particularly to working women. Interestingly though during first
two to four months the number of bleeding/spotting days are increased but the
total volume of blood loss is reduced compared with the woman’s normal
menstruation. However if the woman is dissatisfied with bleeding pattern then
it can be managed by prescribing mefamic
acid tablets (e.g. meftal tablet 500mg) 1 tab twice daily for 5 days.
She should be counseled that with
increasing duration of use she will develop amenorrhea. The rate of amenorrhea
towards the end of the 5 year period of use is around 25 percent. This is of
considerable advantage to women who are already anemic. Reassuringly the
menstruation returns in these amenorrhoeic women within 30 days of removal of
IUS.
IV. Progesterone related side effects:
Progesterone induced side
effects/bloatedness e.g. Breast tenderness, headache, acne and occasionally
depression may occur. These symptoms occur only in few women and pass off as
the release rate of progesterone from IUS decreases. 3) Spontaneous expulsion
of the device. In such an event the women will be unable to feel the thread in
the upper part of vagina. 4) Partial expulsion of the device is also rare. This
should be suspected if the women complain that she is feeling something hard in
the mouth of womb (cervix) or in the upper part of vagina. This may be
associated with pain and cramping. On examination HCP can visualize the lower
part of the vertical limb of the device in the cervix. Normally no part of the
device should be visible. Only the strings should be thus visible. Thus
lengthing of the strings or visualization of part of the device are indications
that the device has come down and is going to expel in no time. In such
situation the device should be removed and a new one fitted.
Wearing Signs:
4)
Persistent
irregular bleeding with pelvic pain: This may mean ‘disturbed
uterine pregnancy’ while IUS still remaining inside or it may be due to ectopic pregnancy (0.02 per 100 woman
years.).
5) Pelvic pain alone: This may be due to pregnancy occurring in
fallopian tube (egg transport tube) torsion of small cyst of ovary or acute
P.I.D. (pelvic inflammatory disease). Thought 10-12% of IUS users exhibit
sonographic evidence of cyst formation but torsion of such small cyst is very
rare (1:2000).
6)
Fever
and pelvic Pain: This
may be due to pelvic inflammatory disease or acquiring fresh STI.
Contraindication:
Absolute contra-indications are a) known or
suspected pregnancy, b) current on recurrent pelvic inflammatory disease, c) lower genital tract infections
particularly mucopurullent cervicities. d) postpartum or postabortal
endometritis i.e. infection of the womb. e) cervical dysplaria f) known or
suspected carcinoma breast g) uterine or cervical malignancy h) leukaemia, i)
valcular diseases of heart j) severe arterial disease.
Additionally women with known disease of
uterus where cavity distortion has
been substantiated by previous investigations (sonography or hystrography or
hystrocopy) then such women should be considered as unsuitable for both IUD and
IUS.
Relative contra-indications are history of
previous ectopic pregnancy, thromboembolic disease, history of ovarian cyst.
Unlike copper bearing devices LNG-IUS cannot be used as emergency
contraceptive.
Health Risks:
4) Pregnancy occurring all side the
womb: The absolute ectopic pregnancy rate is
extremely low with LNG-IUS. The ectopic pregnancy rate of 0.02 per 10 woman
years can be compared very favourably with copper T users (0.25 per woman
years) and sexually active women not using any contraception (1.2-1.6 per woman
years). Nevertheless as LNG-IUS is so effective in preventing intrauterine
pregnancy, if a pregnancy does occur with the IUS still remaining in womb then
there is a high suspicion of being ectopic. The client should be forewarned
about this very rare possibility whenever period is missed and home monitoring
of UPT (Urine for pregnancy test) is positive.
5) Performation of womb: Occassionally performation of womb can
occur particularly when IUS is fitted in early postpartum period when
uterus is soft. Like copper IUD performation can be confirmed by sonography and
will necessiatate laporoscopic removal of the device under general nesthesia.
6) Risk
caused by systemic absorption of progesterone. The blood level while wearing
LNG IUS is 50% less than when women use minipill. Thus of all the hormonal
contraceptives adds minimum hormonal level in LNG-IUS blow this minimizes the
risk to her health. It is very unlikely that such minimal increase of
progesterone hormone in blood will exhibit any adeverse effect on lipid profile
or cause arterial changes.
Timing of insertion of
IUS:
4)
In regularly menstruating women IUS can
be fitted within first six days of commencement of menstrual period. No back up
is needed. If IUS is fitted seven days after commencement of period then
barrier contraceptive should be advocated for next seven days thus that
allowing sufficient time to exert its full contraceptive effect. However
insertion may be planned at any other day of cycle if there is no sexual
intercourse in that cycle.
5)
Six weeks after normal childbirth and
four weeks after induced or spontaneous abortion if there is no clinical
evidence of sepsis. Some people however have suggested fitting LNG-IUS as early
as seven days after an abortion procedure as soon abortion induced pain and
bleeding pass off.
6)
Insertion during lactational ammenohea
has been after performed, with great satisfaction of acceptor. It can be done
as early as 6 weeks but often carried out 8 weeks after normal childbirth. The
use of sounding however is contraindicated during such puerperal insertions
because musculature of womb is still soft and may cause perforation of womb.
The acceptor may be unnecessarily worried about health of child but the daily
amount of LNG excreted in 600ml of breast milk is approximately 0.1% of the
intrauterine daily dose. Thus there is interference in the development of the
newborn.
Follow Up:
First follow up visit may be planned one
week after insertion and later on monthly basis for first three months. Other
after unless there is any complaint no routine follow up is recommended but she
should continue to feel the thread after each menstrual period and be satisfied
that the device has not silent fallen off the womb.
The idea of first follow up arranging so
soon is to discuss with the woman about bleeding symptoms and if there be any
pelvic pain. Additionally she should be encouraged to bear the inconvenient of
bleeding for couple of days. These simple encouraging words or even telephonic
advice will boost up the moral of client to continue the device in spite of minor
sick effects or discomfort.
At follon up visits she should be enquired
about any pelvic pain which may imply either descent of the device or
malrotation of the device while still remaining in womb to achieve near 95%
continuous rate the caregiver should offer ample opportunity to discuss her
concerns about IUS. The staff should be caring, helpful and never dismissive.
HCP should never cloud her doubts but should try to clarify the unspoken
concerns related to IUS. The duty of HCP is to check her blood pressure and
record weight HCP should then perform and interval exception and be satisfied
with the visible part of the length of thread though such interval exertion is
seldom required in intelligent women. However the continuation rate LNG-IUS is
85% after the end of one year and that of copper IUSs is 78%. At last she
should be reminded that LNG-US do not prevent STI and if she considers that
there is a possibility of STI. She should insist on barrier contraceptive in
addition.
Counseling tips:
LNG-IUS is usually very well tolerated in
women who have received careful counseling about the possibilities of irregular bleeding for first two or three
month and subquently amenorrhoea.
But poorly counseled women may become concerned and even request removal of the
device. Thus before fitting IUS it is desirable that counselor should have an unbiased and unhurried discussion with
the acceptor explain pros and cons of IUS. Above all trust and confidence in
the care givers is as important as candid discussion on this costly
contraceptive. Not only the extensive counseling but successful use of LNG-IUS
requires good training of doctors who fit the IUS. In fact acceptance and
continuation rate of any contraceptive method are dependent on technical and
counseling skills of the providers. Further, management of side effects and due
attention to complaints also are important factors for high continuation rate
poor selection of users or poor counseling result in unnecessarily high request
for removal of device.
Copper being devices Vs. LNG-IUS:
Which device to choose? The opinion of
scientists varies in this regard. The side effects, failure rates,
discontinuation rates, spontaneous expulsion rates have been compared by
different health institutions. For average women cheaper T Cu 380 is better as
it has proven efficacy of long 12 years. But after though counseling if
potential acceptor is worried about persistent amenorrhoeic induced by Copper being
IUD the LNG-IUS may be a better option. No doubt women with gynecological
diseases like dysmenorrheal and endometriosis will opt for LNG-IUS. For
interested readers short comparison between the two commonly used devices is
mentioned below –
|
|
Cu T
|
LNG-IUS
|
Cu T
|
LNG-IUS
|
Cu T
|
LNG-IUS
|
|
Cost
|
1-1.4 preg per
100 w years
|
Do
|
|
|
|
|
|
Failure rate
|
8.4 per 100
users
|
11.7
|
|
|
|
|
|
Expulsion the
rate
|
3.6 per 100
users
|
3.6 per 100
users
|
|
|
|
|
|
PID incidence
|
|
|
|
|
|
|
|
Discontinuation
rate
|
|
|
|
|
|
|
Myths & Barriers to LNG-IUS
use:
7)
There device promote pelvic infection
(P.I.D.) thus may invite infertility. In fact IUS do not promote P.I.D.
8)
The risk ectopic pregnancy is
unacceptably high. The reality is that incidence of ectopic pregnancy is
considerably less end in LNG users than general population not using
contraception.
9)
The device may go to inside tummy. The
rate of womb perforation is very rare.
10)
The return of fertility be unduly
delayed. This is not true.
11)
It cannot be used in nulliparous women.
In fact nulliporous women can use it though introduction i.e. fitting of IUS
may be comparatives more difficult.
12)
Women affected with HIV cannot use IUS.
IUS can be used in women affected with HIV though it is considered as category
3 risk. But IUS’ is very effective. So it can be used to achieve near 100%
prevention of pregnancy. Barrier contraception should be used concomitantly to
prevent HIV transmission.
The groing evidence suggest that
barrier contraceptive as commonly used do not prevent pregnancy all the time.
That is the reason why women suffering from STI should avail dual protection i.e. barrier (to
prevent STI) along with some effective contraceptives (to prevent conception).
Take home message:
The LNG-IUS was marketed in US in the year
1995. It is a highly effective contraceptive method which can be safely used
for 5-year period. The release of levonorgestrel (LNG) hormone (progesterone)
inside the womb represents a new approach in contraceptive technology as it
(hormone) exerts local action thus avoids systemic side effects related to
hormone.
The levonorgestrel releasing intrauterine
system (LNG-IUS) continuously release progesterone hormone for at least 5-7
years tus offers an effective ‘estrogen
free long-acting, reversible contraceptive. It offers effective protection against ectopic pregnancy and due to its low systemic steroidal dose, any side effects are mild and few. It can be
fitted four to six weeks after childbirth. It does not affect production if
breast milk neither does it affect growth of infant.
There are some vices as well. The device is
costly and not distributed by Govt. of india nor subsidized by an NGO in
resource poor countries.
Many women do suffer from irregular vaginal bleeding for first few
months which may be annoying to them. But after four to six months most will
have regular periods and by one year majurity will achieve amenorrhoea i.e.
nonoccurrence of monthly periods. Inspite of all thee nuisances LNG-IUS does
not predispose to any health risk. Nevertheless LNG-IUS remains the only option
for w9omen who intend to have long term reversible contraception (no daily
commitment). The other such options are implanon and quarters shots. Subdermal
implant ‘Implanon’ which is effective for three years are not readily available
in most countries including India. Hopefully this will be available in India by
2010.
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LNG IUS (Mirena/Leno Nova):
These IUDs are almost same as copper bearing
IUDs except that the vertical limb of the T-shaped plastic frame is so designed
that it accomodets a small cylinder of progesterone hormone inside. This progesterone filled cylinder continue to
release small amount of progesterone daily inside the womb for five year
continuously. The levonorgestrel releasing intrauterine system (LNG-IUS) has
now become one of the most effective contraceptive methods available.
Additionally this hormonal contraceptive primarily exert its contraceptive
action by topical action on womb and there is minimal rise of progesterone
hormone in blood. Therefore, LNG-IUS has virtually no systemic hormonal side
effect. LNG-IUS thus is a hormonal
contraceptive method with the lowest hormonal does to be tolerated by a
woman. The common brand names are ‘Mirena’
IUS and Levo Nova the Mirena IUS is like many other types of Intrauterine
contraceptive Devices (sometimes located IUCD’s or coils) in that it is lay to
be fited by a doctor and remains in the womb for a fixed amount of time, after
which it must be changed. It is different, however, in that it is much more
effective than usual IUD’s and avoids many of the side effects of copper
containing IUDs.
LNG-IUS exerts contraceptive effect at least for
five years. Nevertheless it continues to release small amount of progesterone
in the fifth and sixth year at a smaller dose i.e. at the rate of 14mcg/day.
Even this small dose is sufficient to effects contraception. After seven years,
however, the contraceptive efficacy falls markedly. Therefore many scientists
now recommended that LNG IUS is effective for seven years. In fact people have
tried for seven years and they are satisfied with its contraceptive efficacy in
last two years also.
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