Wednesday, 12 October 2016

Like to have a long term safe reversible contraceptives ? Use intra-uterine devices made of copper .It is effective for 12 yrs and free . from all Govt. Clinics. His,if properly fitted by trained doctors /Nurses wil have minimal side effects.I stand guarantee..

sera Greetings from Dr. (Prof. Dr. Srimanta Kumar Pal) : drsrimantapal@gmail.com.09333315050.
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 bearing IUD – P, Conclusion – P, Further Reading – P, Webs – P.

1.     The basics of IUDs: The Preface :-
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. 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 Copper IUDs does not interfere with sexual spontaneity. Once introduced the IUD is immediately effective.
2.      It is a regular contraceptive: But does it effect as EC as well??  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. This   is unfortunately little discussed. Health Care Providers (HCP) are to be held responsible for poor use as Emergency Contraception. People will have unprotected sex for the centuries to come but unbiased information should come from doctors and other HCPs as well.
3.    Types of IUDs:--
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.
4.      Classifcation of IUds :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 substances 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.



Further 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.



5.     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 does 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 longitudinal 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.

6. What are the 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 dozens 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, and 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, and New Gersey. It is marketed in India by German Remedies and the approximate cost in India is Rs. 6000/-.

6.     The Newer IUDs :-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’, ‘Fibro plant 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 nulliparous 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.

7.     IUD acceptability: IUD use by Indian women:
There were three National Family Health Survey in India. The study period was 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.

8.     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.
9.     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. non-mdeicated 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) implantation. 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.

10.         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.

11.         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.

12.         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.

13.         Why woman will opt for IUD? Advantages of IUDs as contraceptive:
1)      Immediately effective and very little to remember subsequently.
2)      Can be used during breastfeeding. Does not alter the quantity of breast milk.
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 transversal 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.

14.  Contraindications of IUDs : 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 up to 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 consent 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 intraepithelial 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.

15.         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 women 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.

16.         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.

17.         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 that 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 myoma does 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.

18.         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.
19.         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.-Further information will follow.

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