Thursday, 13 October 2016

Intra Uterine Contraceptive Coil -is an important Contraceptive Device-to be fitted inside the womb by a doctor / Trained Nurse.The device has many virues but can sometimes fail.Let us know the degree of contraceptive efficacy of Copper containg Intra uterine contraceptive Devices.

Copper Containg Intra Uterine Contraceptive Coils-Has some side effects and few failure Rates. What are those drawbacks of Device which is fitted inside the womb?
We must be aware of      Newer Copper IUDs:
  What are the drawbacks of Copper bearing IUDs as contraceptives? 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 nulliparous 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 can induce PID is fast fading.
4)      Discomfort during fitting: /Procedure-Related discomfort or Mild Cramp in tummy           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 judgment 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.(Intra Uterine Contraception).
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)      Misplacement of IUD:   Physicians Fault-Incomplete Training.        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.

Who are unsuitable for wearing IUDs ?   Not every women are fit or ideal candidate for IUDs : Risk stratification of women as per WHO guidelines: Doctors should nit fit IUDs to whoever approaches him : STOP-LOOK-GO.
            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 risks mean 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 have it intensified 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.

34. Failure rate of IUDs resulting in 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 malpositioned of the IUD can often be minimized 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 foetus.

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 occurring 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.

Possibility of having Ectopic Pregnancy while the device is still inside the uterus :  (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 varies 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 THAT 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.

We must be aware of      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 clinical trials the device has proved to be highly effective and comfortable to use. A Copper bearing IUD with a T-Shaped frame, called the Saf-T is becoming popular at Switzerland  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.
            Cervical IUDS which remains in the mouth of womb(not inside the womb) Fibroplant and Degradable IUDs are becoming fast popular.

The very purpose of these new devices is to reduce pain and irregular bleeding associated with in the existing copper bearing 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 more likely / bound 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.

Thanks. Prof. Srimanta Kumar Pal. Berhampore, WB, India .






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