Why
Contraceptives occasionally fail?
Many a woman
become pregnant surprisingly in spite continued use of contraceptives. These
pregnancies are designated as ‘contraceptives failures’ or ‘contraceptive
accidents’. In selected case the contraceptive failure may be due to inefficacy
of the method used. These pregnancies are designated as method failure. Such on unfortunate event may also result from
user’s inconsistent use of the choiced contraceptive or use wrong of the method
in a way. If accidental pregnancy does occur is such case it is called user
failure.
Classification of acceptors:
Based on the
degree of motivation acceptors are classified as ‘typical users’ and ‘perfect
users’. Typical users are women
or men of average intelligency and motivation who use the contraceptive method
casually. Conversely, there is another group of contraceptive acceptors where
the choiced contraceptive is used strictly as per norms and instruction issued
by the concerned authority. For instance in case of oral contraceptives these
second type of women take the pills regularly at a definite time of this day as
per advice communicated to them by physician. These contraceptors one called
‘perfect users’.
So far as IUC
is concerned the difference between two subsets of acceptors are minimal.
‘Perfect’ and ‘typical users’ are nearly identical. In fact IUC ‘compliance’ is
limited to monthly string checks.
In summary,
the IUD is 98-99% effective, which means that of 100 women using the IUD, about
1-2 will become pregnant during the first year of use. By comparison, sixty to
eighty women who use no birth control method is likely to become pregnant in
one year period, provided couple are healthy. If the copper IUD is used for
twelve year and LNG IUS for 7 year period then provide cumulative pregnancy
rates will be 1.9 per 100 women for the copper IUD and 1.1 to 1.4 pregnancies
per 100 women with the LNG IUS. However, the cumulative 10 year probability of
pregnancy after tubal ligation is 1.8 per 100 women, not clinically different.
Thus modern IUC can be considered as ‘reversible
sterilization’ – without the risk of anesthesia, surgery, or regret for the
woman or her partner.
Appendix – XIII
Factors
which affect contraceptive efficacy & continuation rate:
To compare ‘real-life effectiveness of different
contraceptive methods’ several factors must be considered. Firstly how well
does a method prevent pregnancy? Secondly how easy or difficult is it to be
compliant with the method in order that use will be consistent and accurate?
Thirdly, what is the method’s continuation rate?
If side
effects or cumbersome compliance requirements make women discontinue or use
method erratically, effectiveness over time plummets. The real-life
contraceptive effectiveness equation helps put the many important factors
influencing effectiveness into perspective. Thus real life contraceptive
effectiveness equation is as follows:
Appendix - XVI
Brand names of
pills available in India and number of tablets to be taken if used as emergency
pills:
COC as EC:
How many pills to be taken?
Composition
and Formulation
|
Brand
Name
|
Estrogen
|
Progestrogen
|
No. of tablets
to be used at
12 hours interval
|
|
Ovral
|
Ethinyl
estradiol: 0.05mg
|
Levonogestrel:
0.25mg
|
2+2
|
|
Ovral
L
|
Ethinyl
estradiol: 0.03mg
|
Levonogestrel:
0.15mg
|
4+4
|
|
Mala
D
|
Ethinyl
estradiol: 0.03mg
|
Norgestrel:
0.30mg
|
4+4
|
|
Mala
N
|
Ethinyl
estradiol: 0.03mg
|
Norgestrel:
0.03mg
|
4+4
|
|
Femilon
|
Ethinyl
estradiol: 0.02mg
|
Desogestrel:
0.15mg
|
5+5
|
|
Pearl
|
Ethinyl
estradiol: 0.03mg
|
Norgestrel:
0.03mg
|
4+4
|
|
Loette
|
Ethinyl
estradiol: 0.02mg
|
Levonorgestrel:
0.10mg
|
5+5
|
|
Novelon
|
Ethinyl
estradiol: 0.03mg
|
Desogestrel:
0.15mg
|
4+4
|
Note: Triphasic pills
should not be used as EC to avoid miscalculation of dosage. Only white colored
tablets should be used while prescribing Mala N, Mala D or Pearl as ECP (i.e.
28 pill packs where red pill are non-hormonal iron tablets).
Oral
contraceptives as available abroad:
(Dose as EC)
|
Pill Brand
|
Manufacturer
|
1st Dose
|
2nd Dose (12
hours later)
|
|
Alesse
|
Wyeth-Ayerst
|
5
pink pills
|
5
pink pills
|
|
Levlen
|
Berlex
|
4
light orange pills
|
4
light orange pills
|
|
Levlite
|
Berlex
|
5
pink pills
|
5
pink pills
|
|
Levora
|
Watson
|
4
white pills
|
4
white pills
|
|
Lo/Ovral
|
Wyeth-Ayerst
|
4
white pills
|
4
white pills
|
|
Low/Ogestrel
|
Watson
|
4
white pills
|
4
white pills
|
|
Nordette
|
Wyeth-Ayerst
|
4
light orange pills
|
4
light orange pills
|
|
Ogestrel
|
Watson
|
2
white pills
|
2
white pills
|
|
Orval
|
Wyeth-Ayerst
|
2
white pills
|
2
white pills
|
|
Ogestrel
|
Watson
|
2
white pills
|
2
white pills
|
|
Orval
|
Wyeth-Ayerst
|
2
white pills
|
2
white pills
|
|
Tri-Levlen
|
Berlex
|
4
yellow pills
|
4
yellow pills
|
|
Triphasil
|
Wyeth-Ayert
|
4
yellow pills
|
4
yellow pills
|
|
Trivora
|
Watson
|
4
pink pills
|
4
pink pills
|
|
Preven
|
Gynetics
|
2
blue pills
|
2
blue pills
|
**PREVEN: Packet is meant for ECP only (Special pack) but contain
oestrogen and progesterones.
Selected brands and doses of hormonal contraceptive
products used for emergency contraception:
|
Brand
|
Dosing
|
EE/Dose (mcg)
|
LNG/Dose (mg)
|
|
Dedicated
product (2-dose regimen, administered 12 hours apart)
|
|||
|
Plan
B
|
1
white tablet/dose
|
0
|
0.75
|
|
Combination
OCsa (2-dose regimen, administered 12 hours apart)
|
|||
|
Aslesse
|
5
pink tablets/dose
|
100
|
0.50
|
|
Levlen
|
4
light orange tablets/dose
|
120
|
0.60
|
|
Levlite
|
5
pink tablets/dose
|
100
|
0.50
|
|
Levora
|
4
white tablets/dose
|
120
|
0.60
|
|
Nordette
|
4
light orange tablets/dose
|
120
|
0.60
|
|
Ogestrel
|
2
white tablets/dose
|
100
|
0.50
|
|
Seasonale
|
4
pink tablets/dose
|
120
|
0.60
|
|
Tri-Levlen
|
4
yellow tablets/dose
|
120
|
0.50
|
|
Seasonique
|
4
light blue-green tablets/dose
|
120
|
0.60
|
|
Lo/Ovral
|
4
white tablets/dose
|
120
|
0.60
|
At: http://ec.princeton.edu/questions/dose.html#dose. Accessed
January 4, 2008.
c) Mifepristone
(RU 486) drug as ECP?
A single dose of mifepristone 50 mg.
taken within 5 days of unprotected intercourse is highly effective for
emergency contraception. As a matter of fact low 20mg or even 10mg may be
effective. But in India only 200mg is available in trade. It has a low
incidence of side-effects. However, 9-18% of women experience a delay at
meanses at more than 5 days. Women should be co0unselled appropriately. A major
constraint for the use of mifepristone is its cost.
Brand Name – Mifegest, Mifeprin,
d) Copper-releasing IUDs as emergency contraceptive:
The copper-releasing IUD is also
highly effective for emergency contraception. 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 an IUD for emergency contraception,
the eligibility criteria are the same as those for regular use of these
devices. However recent studies reveal that it may be effective up to 7 days of
unprotected coitus in some causes.
Brand Name – Monalisa, ML Cu-T 375:
Efficacy:
High dose progesterone tab (ECee-2,
Pill 72). i.e. the levonorgestrel only regimen is preferred because it is more
effective and is associated with a lower incidence of side effects.
However, treatment with any regimen
should be initiated as soon as possible after intercourse because data suggest
that efficacy declines substantially with time. Both mechanical and chemical
(i.e. tablet) regimens have been shown to be effective through five days (120
hours) after intercourse. Longer delays have not been investigated properly but
IUD and Mifepristone pill may be
effective up to 7 days. One should remember that expected pregnancy rate or
any day of menstrual cycle is 2-4% per cycle in healthy couple but if
intercourse occurs in mid-cycle i.e. 24-48 hours prior to ovulation than the
chance of pregnancy from one act of intercourse will be 15-30% per cycle in
healthy couple conceivably, contraceptive efficacy of different EC is difficult
to evaluate because pregnancy rate will vary depending on the time of unprotected
coits.
Success rate of EC depends on how soon drug is taken
poscoitally or an IUD is fitted inside the uterus:
However, the effectiveness of
emergency contraception is compared with the pregnancy rate without treatment,
which varies throughout the menstrual cycle. As stated earlier the risk of
pregnancy after unprotect sex highest around the time of ovulation (20-30%) the
residual risk of pregnancy even after taking oral emergency contraceptive is
used at this stage of the cycle is
greater than the residual risk when EC is used at a time in the cycle when the
risk of pregnancy is low (2-4%). When the risk of pregnancy is low (when with
cause occurs at a time other than day 10 to day 18 of cycle then oral ECP will
exert very great efficacy. EC reduces the risk of less than 1% and when the
risk of pregnancy is high I reduces the risk to around 5% from 20-30%.
The residual risk of pregnancy risk
even after taking EC may therefore remain unacceptably high for some women and
an intra-uterine device (UD) may be a better option. So if coitus occurs
immediate in-medically IUD is better progestin-only ECPs reduce the risk of
pregnancy by 89 percent. Only one woman out of 100 who had unprotected sex will
become pregnant after taking progestin-only ECPs. The success ate however, decreases with each 12 hours
delay. Every effort should be made to take the medication as soon as
possible. The IUD is more effective form of emergency contraception, with less
than 1% failure rate. But IUD could not be put in unmarried women and better be
avoided in nulliparons women. The risk of pregnancy may also therefore be
influenced by recall of the date of the last menstrual period and whether the
woman experiences regular-length cycles or not.
Nevertheless increased used of EC
has substantially lower the rate of unintended pregnancy. The overall
protection provided by EC is reported in various studies to be approximately 75
percent (range 55 to 94 percent). Thus pregnancy even after use of EC occurs in
about 20 percent of women depending upon day of cycle on when unprotected sex
occurred and delay in taking the pills. The author likes to remind the readers
that EC regimen should not be used as an ongoing contraceptive method. This is
because EC has a monthly pregnancy risk of two percent which translate to an
unacceptably high 24 percent annual rate of risk. The description whichever now
follows related to high dose progesterone pills (dedicated ?????????? pills)
because other two types of EC pills (??????? Oral contraceptives and Mifepristone
tablet) and intrauterine device are seldom ??????????. However, details of this
method have been described in appendix. Author has been prescribing EC since
2000 and as has counseled about 2000 such women who either personally need at
clinic or songettelephonic advice. Unfortunately only 2000 women out of agreed
to IUD insertation as postcoital contraceptive and none to combined oral
contraceptive. Author has written books on EC and several articles in local
daily and periodicals (e.g.) Sanonda in West Bengal, India Year? To popularize
the method. Unfortunately sadly today even as on 2009 few Indian women use this
all important drug at appropriate time. Many couple under evaluate the efficacy
of this drug and prefer to proceed to abortion if pregnancy eventually occurs.
On set of menstruation:
After using emergency oral
contraception, up to 98 percent of patients menstruate within 21 days of
treatment. In more than one half or patients, menses occurs at the expected
time. In more than 90 percent of cases, menses will be of normal (for that
woman) duration. Whether the patient has a history of regular or irregular
menstrual cycles does not appear to be a contributing factor. If the emergency
contraception treatment is given before ovulation, menstrual bleeding may begin
three to seven days earlier than expected. If the treatment begins after
ovulation, menstrual bleeding may come at the expected time or be delayed. It
is important for the patient to seek prompt medical care if menses has not
started within 21 days. (Source: American Family Physician).
Changes in
menstrual cycles following use of levonorgestrel emergency contraception:
|
Change in Cycle
|
|
|
Delayed
menses*
|
5% to 15%
|
|
Heavier
menses
|
11% to 14%
|
|
Irregular
bleeding
|
3% to 30%
|
High dose Progesterone pills (dedicated EC):
This class of EC is possibly most
safe and easy to follow by the clients. EC can be used in subjects including
women suffering from high BP, anaemia, heart disease and diabetis. No medical
disease has an adverse effect on this class of ECP. History of ectopic
pregnancy is not a contraindication to use of the dedicated LNG product. Thus
there are no absolute contraindications to use except known pregnancy. EC not
continue to prevent pregnancy during the rest of the cycle. Other methods of
birth control must be used if repeated act of intercourse occur or the same
cycle after taking first dose. Emergency contraception offers no protection
against sexually transmitted infections. One should always consider testing for
sedxually transmitted infections if there possibility that unprotected sex has
put someone at risk of STI. (e.g. rape).
Failure rate is 0.16-5.0% depending
on time of cycle when intercourse occurred.
Side Effects:
1)
Nausea and
vomiting:
Anti-emetics may reduce the
incidence of standard nausea and vomiting but routine administration is not
recommended with regime pills containing high dose progesterone. If an
antiemetic is prescribed, the client should be informed about the usual
side-effects of these such as dizziness, and she should be advised to avoid
driving, operating machinery and taking alcohol. Vomiting occurring within 2
hours of taking pill necessitates an additional dose or use of an alternative
method.
2)
Bleeding:
Any irregular bleeding or
spotting after EC use should not be misunderstood as periods. Next menstrual
period may occur one week prior or later than the expected time. Women having
excessive or prolonged bleeding should be evaluated for pregnancy
(intra-uterine or ectopic) and its sequences.
The amount of bleeding in the following period is usually
normal but slightly heavier or lighter flow may be expected.
3)
Missed
period:
A delay of 7 days from the
expected date of periods may observe in 13% of women. To allay the anxiety of
the client and for earlier diagnosis, a urine pregnancy test may be done when
delay is more than one week. If negative at this stage one can wait for another
one week. However, pregnancy test is mandatory if the periods are delayed by
more than two weeks from the expected date, and then one should act according
to the report.
4)
Other
side-effects:
Side effects like headache,
mastalgia, dizziness, giddiness, abdominal cramps etc. are usually minor and
self limiting. Simple analgesics, can be prescribed if these are disturbing.
However, ectopic pregnancy is
possible in women who become pregnant after using LNG EC and should be
considered in any woman who complains of lower abdominal pain.
Levonorgestrel emergency contraception Common Side
effects:
|
Adverse
Event
|
|
|
Nausea
|
12% to 23%
|
|
Abdominal pain
|
14% to 18%
|
|
Fatigue
|
8% to 17%
|
|
Headache
|
11% to 17%
|
|
Dizziness
|
4% to 11%
|
|
Breast tenderness
|
3% to 11%
|
|
Vomiting
|
1% to 6%
|
|
Diarrhea
|
1% to 5%
|
Appendix – XVII
Mifepristone:
Mifepristone is known as abortion
pill. It is used globally for medical abortion.
Dose Schedule:
The dose has not been standardized as yet so far as its use
as ECP is concerned. Usually a dose of 100mg is taken within 120 hours after
unprotected coitus. It is more effective than classical pills (e;g. pill 72,
Ecee-8 2 etc.) and traditional oral contraceptives. The brand names in India
are Mifegest, MT Pill, Mifeprine. Even a dose of 10mg of mifepristone is
sufficient for emergency contraception. Earlier treatment is porferable, although the method can be used effectively for up to 5 days after
intercourse.
However, these pills do not contain any hormones. The
substance which is an antiprogesterone blocks the action of progesterone, a
natural body hormone, which is essential for establishment and continuation of
pregnancy. Mifepristone is the name of this antiprogesterone substance. It is
also called French abortion pill.
Mifepristone prevents the release of the egg from the ovary.
This is the main mechanism of action as EC regimen.
Mifepristone (RU-486) is excellent in preventing an
unintended pregnancy. The success rate is 99% to 100%. Mifepristone has ben
available in Europe since 1987. In 2000 it was also approved for use in the
U.S., where it is available through a physician’s office. The FDA has only
approved its use for Medical Termination of Pregnancy, however, it may be used as an Emergency Contraceptive as
an of-label use.
As with other EC regimens, the sooner one take this pill
after unprotected sex, the better. Also, one dose only works against one single
act of unprotected sex. So, one must use a back-up birth control method, if she
have sex again before the start of her next period. Barrier methods, like the
sponge or the diaphragm are good back-up options. This class of EC pill also
does not protect against Sexually Transmitted Infections (STIs).
The main side effects of Mifepristone are nausea, vomiting
and stomach cramps.
The safety of Mifepristone is excellent. There are no contraindications
to using it, except a known pregnancy.
IUD as an emergency procedure:
This is the most effective method of postcoital contraception currently
available. It is particularly appropriate for women who wish to use the IUD as
a long-term method of contraception.
The copper IUD can be inserted up to
five days (120 hours) after unprotected intercourse. It is thought to act by
changing the endometrium to make implantation unlikely. There is no evidence
that the copper IUD usd as a postcoital contraceptive in this way is
abortifacient. The intrauterine system, or Mirena, is not for postcoital use.
The
side-effects of using this method are similar to those of other IUDs. It is
good practice to take swabs before fitting an IUD and, if there is a strong
suspicion of a sexually transmitted infection, to prescribe antibiotic cover at
the time of insertion. The most likely infection is Chlamydia; to ensure
compliance, a single dose (1g) of azithromycin could be given. Microbiological
investigations must be followed up an contract tracing performed. A woman may
choose to have the IUD removed at the next menstruation i.e. temporary use of
copper IUD.
Appendix – XXVI
Two rates are reported for each
method. One is the pregnancy rate for the method as commonly used. This is a
typical, or average rate. A specific couple may be more successful or less
successful than this – sometimes much more or much less. The other rate is the
pregnancy rate when the method is used correctly and consistently. This is about
the best rate that a user can expect from the method.
Contraceptive Efficacy:
|
Effectiveness Group
|
Family Planning Method
|
Pregnancies per 100 Women in first 12 Months of
Use
|
|
|
As commonly Used
|
Used Correctly & Consistently
|
||
|
Always very effective
|
Norplant implants
|
0.1
|
0.1
|
|
Vasectomy
|
0.15
|
0.1
|
|
|
DMPA and NET-EN
injectables
|
0.3
|
0.3
|
|
|
Female sterilization
|
0.5
|
0.5
|
|
|
TCu-380A IUD
|
0.8
|
|
|
|
Progestin-only oral
contraceptives
|
1
|
0.6
|
|
|
Effective as commonly
used. Very effective when used correctly and consistently.
|
LAM (for 6 months only)
|
2
|
0.5
|
|
Combined oral
contraceptives
|
6-8
|
0.1
|
|
|
Only somewhat effective as
commonly used. Effective when used correctly and consistently.
|
Condoms
|
14
|
3
|
|
Diaphragm with spermicide
|
20
|
6
|
|
|
Fertility based awareness
methods
|
20
|
1-9
|
|
|
Female condoms
|
21
|
5
|
|
|
Spermicides
|
26
|
6
|
|
|
No method
|
|
85
|
85
|
LAM is used for no more than 6
months after childbirth. Doubling these rates would give 1 year rates for
comparison with other methods.
The main objective of any good contraceptive is to provide
safe and effective contraception. However, the efficacy and safety varies with
the method. But there is enough data on safety and efficacy or various methods.
There is not enough data or information about non-contraceptive uses/benefits
of various methods of contraception.
As mankind has stepped in few
millenniums, certain things need to be clearly understood. Freedom means the
ability to determine choices. And no choice is greater than the role one wishes
his or her biological functions to play. For a woman, childbearing is
fundamentally important to her identity, as a mother, as a woman, and a member
of society. She should therefore, conceive only when she feels ready for the
event.
Therefore one can say that “Fertility should not be by chance but by
choice”.
Theoretical effectiveness is the
maximum effectiveness of that method-its effectiveness when used without error,
when used perfectly, and when used exactly according to instruction.
Use effectiveness takes into account
all users-those who use the method without error and those who are careless.
>98% Very effective
95% - 98% Moderately effective
<95% Poorly effective
There are two measurements. Method
effectiveness and user effectiveness. Method effectiveness measures the number
of times pregnancy occurs when the method is used exactly the way it is
supposed to be used. An example of this would be to take a contraceptive pill,
without fail, every single day for the 20 days required in a particular month.
If, in spite of this, she gets pregnant, that would be a method failure. Let’s
take a woman, however, who forgets to take one or perhaps two pills during the
month and then gets pregnant. This would be an example of user effectiveness.
Dr. Robert Hatcher of Emory University has created tables showing the
approximate number of pregnancies during their first year of use. He gives two
rates: one for the method when “used correctly and consistently,” and the other
as the “average U.S. experience among 100 women who wanted no more children.”
Debate on Quarterly Shots (A Shot in the dark!)
Few topics related to women’s health
movement are as controversial as contraception. Contraception gives women the
choice to control their own reproduction. However, this control is lost when
contraceptives, many of them invasive and harmful, come as a package deal with
population control programmes that select, motivate and, whenever necessary,
coerce helpless targets. Medicine, policy and decision making and research are
male dominated areas.
Long acting hormonal contraceptives
include injectables such as Depo-Provera (depot medroxy progesterone acetate), and
Net-Oen (norethisterone oenanthate), implants (Implanon), and recently,
anti-fertility vaccine (due to come in the market). Progesterone is one of the
female reproductive hormones and its regulated presence along with the hormone
oestrogen, is essential for successful pregnancy. Depo-Provera Net En and are
contraceptives used as depots of progesterone (or its chemical relatives),
injected in the women. Continuous rather than cyclical or periodic presence of
progesterone is one of the majo0r causes for various side-effects and problems
associated with the usage of injectable contraceptives. Side effects are also
related to the fact that a very high dose of hormones is delivered by the
injecton.
Contraception is clearly not the
sole responsibility of the woman. Therefore, women’s groups are constantly
questioning as to why there is more research into contraceptives for women as
compared to those for men.
There was long debate about safety
of quarters shots. The main health hazard is breast cancer. The other health
risk which may be associated with Inj. DMPA are osteoporosis, teratogenesis,
delay in return of fertility and anaemic resulting from long standing menstrual
irregularity which women offer end use. The other possible side effects which
are prolonged menstrual bleeding episodes, spotting in the first three to six
months, severe abdominal cramps, amenorrhea or permanent loss of periods,
weight gain of up to two kilos, nervousness, dizziness, fatigue, liver
disorders and harm to bone density.
Many NGO objected to introduction of
Inj. DMPA in India but Medical profession and Govt. of India cited who were
proponenis of the Injectable Contraceptives claim that it has no
life-threatening side-effects and that its benefits outweigh its risks.
Though the Supreme Court had
initially stayed introduction of the contraceptive following a petition by a
Gujarat based NGO, the petition was cancelled and the ministry promised to the
court that it would introduce injectables gradually, restricting them first to
urban centres, especially medical college hospitals where facilities for
monitoring and care are available.
But questions still dog the
controversial contraceptive, especially over the question of “informed choice”.
Would the women who would be using Net En truly be exercising their choice when
so many of them have no control over the bodies and the number of babies they
wish to have?
In 1986, Stree Shakti Sanghatana of
Hyderabad, along with Saheli of New Delhi filed for a stay order on the trials
which were being carried out without the informed consent of the subjects.
Among the grounds cited for filing the petition are:
The injectable should not be administrerd
without making public all the information regarding the drug; the authorities
have no right to initiate an injectable programme without adequately equipping
the rural and urban health centres and providing adequately trained staff for
follow-up care; the experiment with the injectable violates women’s fundamental
rights under Article 21. Population control may be one of the laudable
objectives but while implementing it the governmental agencies have no
authority to violate human dignity or the right to be informed or the right to
a healthy life.
The injectable ensures transfer of
control from the hands of the user to the hands of the health personnel who
wield the syringe.
In countries where Depo is used on a
large scale, women were not given enough information about it. In countries
like India, as almost everywhere else, poor and illiterate women from rural
areas were chosen for trials.
Doctor’s view on DMPA – The doctors less stress on the
risks and benefit theory.
Appendix – XXXI
Composition of Oral Pill Is DMPA
|
Index
|
OCs
|
DMPA
|
Cu IUD
|
|
Efficacy
|
User dependent
|
High
|
High
|
|
Length of protection
|
Continuous if taken daily
|
3 months
|
10 years
|
|
Rapid return of fertility
|
Yes
|
No
|
Yes
|
|
Regular cycles
|
Yes
|
No
|
Yes
|
|
Amenorrhea
|
Uncommon
|
Common
|
No
|
|
Appropriate in lactating
mothers
|
Suboptimal
|
Yes
|
Yes
|
|
Procoagulant
|
Yes
|
No
|
No
|
|
Non-contraceptive benefits
|
Established
|
Established
|
No
|
|
Provider required to
initiate
|
Yes
|
Yes
|
Yes
|
|
Provider required to
discontinue
|
No
|
No
|
Yes
|
|
Privacy
|
Requires pill pack
|
Yes
|
Usually
|
Appendix – XXVII
Grading of Contraceptives so far efficacy is concerned
Very Effective: Pregnancy rates
between 0-1 per 100 women in first year of use.
Effective: Pregnancy rates between 2-9 per 100 women in first year of
use.
Somewhat Effective: Pregnancy rates between 10-30 per 100 women in
first year of use.
Appendix – XXVIII
Relevance of long acting Contraceptives
Beneficial
effects of long term hormonal contraception
-
Reliability of administration with high degree of
motivation from the subject
-
Long duration of action with ready reversibility
-
The continuous release of steroid achieves an
anti-fertility effect with doses lower than those used in oral contraceptives.
-
A fairly constant blood concentration of the steroid
instead of marked fluctuations or high peak concentration seen on oral
administration
-
Low daily dose means fewer side effects
-
Adoidance of first-pass effect and imcomplete
absorption due to GI disorder; the latter particularly important in countries
with high prevalence of gastrointestinal diseases
-
Suitablility for lactating women sicne it is unlikely
that lactation will be inhibited and negligible quantities are likely to be
transferred to the infant
-
Attendance at the clinic are minimized
Appendix – XXIX
Steroidal Contraception
Haberlandt in 1921 demonstrated that
by implanting an ovary from a pregnant guinea-pig or a rabbit, fowls were
rendered sterile temporarily. In 1934, crystalline progesterone was isolated by
several groups of investigators and its chemical structure was established by
Butenandt and co-workers. Although by 1937, it became known that progesterone,
testerone and oestrogen could inhibit ovulations, these hormones were not of
much practical use until 1954 when Djerassi and co-workers developed a new
method of synthesis of orally active progestogens, following which, a large
number of 19-nortestosterone derivatives appeared.
???????????????????????
Types of steroidal contraceptives
Appendix – XXVI
Evaluation of Injectables Contraceptives
However researchers developed the
first monthly injectables and conducted clinical trials in the 1960s. The
combination of progestin and estrogen that became Cyclofem was first tested in
1968, and the combination the became Mesigyna was first tested in 1974.
1950 – The first systemic
contraceptives were developed for short acting progestogens for oral use.
1953 – Junkmann and his associates
developed first injectable progestogen with long acting effects.
1953 – Medroxy Progesterone was
developed by Upjohn Company.
1957
– Schering developed, NorEthisterone Oenanthate.
Originally used for
Endometriosis and Threatened abortions.
1963 – First contraceptive trial was
started.
1966 – Efficacy reports published.
1974 – FDA withdrew the approvalin
view of certain adverse results. Initial clinical trials advised 150mg of
Depo-Provera every 3 months.
1979 – WHO recommended the DMPA to
be used as Contraceptive agent.
1984 – UK approved injectables as
first line contraceptives.
Injectables were initially a result of
research rollowing the war, when in 1953, Dr junkman found that a long-acting
injection was created if progestogen and alcohol were combined.
In 1957, research began on the
injectable Norigest, now known as Noristerat, which is licensed for short-term
use in UK, i.e. following administration of the rubella vaccine. In 1963,
trials commenced on the injectable Depoprovera, which was licensed in the UK
for long-term use in 1984 when other methods were not suitable. Since 1990, it
has been licensed as a first choice method.
Appendix – XXIII
How safe is Inj. Depot Progeserone.? What are yhe
different Controversies with Quarterly
Shots.(inj Depo Provra)? Are these
simply rumors or there is some truth behind??
Since it was first introduced as a
contraceptive in 1965, Depo Medroxy Progesterone Acetate (DMPA) had to traverse
a difficult and a path which was and still is serpeginous with ups and down
path.
Breast
Cancer: No
increased risk overall, but the study found that XMPA users had an increased
risk for several years after starting. DMPA-perhaps due to accelerated growth
of existing tumors. Some of the apparent increase in risk may be explained by
detection bias.
Cervical
Cancer: No increased risk of
invasive cancer.
Endometrial
Cancer: Protective effect.
Ovarian
Cancer: No increased risk.
Liver
Cancer: No increased
risk.
The findings about breast and endometrial
cancer were the most crucial because they answered the long-standing questions
raised by animal studies.
Appendix – XXX
Contraceptive
Steroids:
a)
Estrogens:
Ethinyl estradiol
· Menstranol
b)
Progestins:
· Ethynodiol
diacetate
· Norethindrone
· Norethindrone
acetate
· Norethynodrel
Norgestrel
Norgestimate
Desogestrel
Gestodence
* Not used now-a-days
Appendix – XXV
How are injections disposed in the trade?Injection procedure
(Depo-Provera)
It is available as 1ml nil which
contain the dosage of Depo-Provera 150mg. This is to be given deep intra
muscular every 3 months. Usually 2ml syringe and 21 gauge needle are supplied
with the package. The need and syringe manufactured for single use and must be
safely disposed off following administration.
The wash his/her person and
???????????????? the injection should hands thoroughly with soap and water.
The 1ml vial of Depo-Provera should
be vigorously shaken just before use to ensure that the dose being administered
represents a uniform suspension.
The alcohol should be allowed to dry
before administering the injection.
The client should not to message the
area after the injection. Massaging may accelerate the release of progestin,
hormone shortening the period of efficacy. It may also disperse the injection
so that it is not properly absorbed.
Appendix – XXXVIII
Menstrual abnormality associated
with quarterly shorts/Minipills or subdermal Implant (Implanon)
Regular patterns of vaginal bleeding
are central to beliefs concerning fertility, absence of pregnancy, and
reproductive health for woemen from many cultures. In addition, for some women
the presence of irregular or unpredictable bleeding is a barrier to social,
sexual and cultural activities and hence, represents a major distruption to
their lives. Because rregular bleeding may also be a feature of infection of
the genital tract, and of malignancy, this symptom may also prompt additional
investigations, such cervical cytology, colposcopy, or even endometrial biopsy.
The need to wear a pad or tampon at
all times is uncomfortable and becomes expensive when bleeding is prolonged.
Hence, it is not surprising that disturbances of menstrual bleeding are
consistently the most commonly stated reason for patients to discontinue
implantable contraceptives. Although irregular bleeding is tolerated by many
women, some are prepared to accept amenorrhea in the context of adequate
support and explanation.
The maximum disruption of bleeding
occurs in the early months of use, with between 40-70% of discontinuations in
clinical trials caused by these disturbances.
If had previously been held that the
endometrial microvessels themselves do not display receptors for estrogen and
progesterone nd, hence, that the effects of these sex steroids must be
indirect-Recent observations suggests that progesterone receptors are expressed
in this tissue and that long-term progesterone exposure leads to suppression of
endothelial cell proliferation, irhibition of migration, and increased
statement of MMP-9. The functional role of these microvessel receptors requires
further clarification, but the overall effect of these vascular changes may be
to increase endometrial vascular fragility.
Because endometrial vascular and
epithelial break down must occur before vaginal bleeding is seen, the focus of
recent investigations into DMPA related irregular bleeding has focused on
endometrial blood vessels and the local control of their growth, breakdown, and
repair. In cases of persistent irregular bledding there is focal following
exposure to both low and high dose progestogens. There is insufficient
information about the pattern of vessel breakdown in normal menstrual cycles to
know whether focal bleeding usually occurs or is peculiar to BTB. Focal
bleeding suggests that the agents precipitating endometrial breakdown may be
unevenly activated in the tissue, or that endometrial vessels respond
diccerently of there agents. Sampling the endometrium from bleeding sites in
women using Depo-Provera revealed that statement of tissue factor (TF), the primary initiator of homeostatis, was
reduced at these sites and that statement of progesterone receptors A and B were lower in these regions. Studies
sampling bleeding and non-bleeding episodes may throw further light on this
issue.
No comments:
Post a Comment