N.C. Saxena

Evaluating contraceptive choice through the method-mix approach: An Indian Council of Medical Research (ICMR) Task Force study

The method-mix approach was used to evaluate informed contraceptive choices in the present study. A total of 8,077 potential clients were given a balanced presentation of all available contraceptive methods in the national program, ie, the CuT 200 intrauterine device (IUD), low-dose combined oral pills (OC), condom, and sterilization (female/male) along with a new method, Norplant(R).(1) The majority of women opted for spacing methods; among them, the IUD was preferred by about 60% of clients, followed by condoms (9%), OC (6%), and Norplant (5%). Sterilization, mainly female, was accepted by about 17% of the women making an informed choice. The economic status of couples did not influence the contraceptive choices, as all the methods were offered free of cost in the present study, which is the current practice in the national program. Illiterate women more often accepted sterilization (about 25%) than did literate women (15%). This is because illiterate women had more children; about 30% of illiterate women had three or more children, as opposed to 16.2% of literate women. However, literacy status did not influence the choice of any specific spacing method. The study also revealed that, by encouraging potential clients to make an informed choice, they could override the providers bias while accepting a particular type of spacing method. This is evident from the observation that Norplant was the first choice of the provider for 35% of the women, whereas only 5% of women preferred and accepted Norplant. The present study stresses an urgent need to promote the practice of informed choices in the national program with a variety of contraceptive options-especially, spacing methods for improving contraceptive prevalence and reproductive health in the country.

Comparative evaluation of contraceptive efficacy of norethisterone oenanthate (200 mg) injectable contraceptive given every two or three monthly

A total of 2388 subjects, 1181 for 60 +/- 5-day and 1207 for 90 +/- 5-day treatment regimen with norethisterone oenanthate (NET OEN) 200 mg injection, were observed for 24 months, constituting 28,513 woman-months. This clinical trial represents the largest clinical trial undertaken on NET OEN. The observations indicated that NET OEN given at 60 +/- 5-day intervals provides adequate contraceptive protection. However, as compared to the published studies elsewhere, higher method failures were seen during the first six months of NET OEN usage, when all women were receiving the drug at 60 +/- 5-day intervals. The reasons for this discrepant observation in the present study cannot be explained. The higher method failures reported with 90 +/- 5-day regimen were mainly during the third month following the injection, suggesting reduced contraceptive efficacy of the drug during this period. Thin build women (body weight less than or equal to 40 kg) were at higher risk of involuntary pregnancy. Disrupted menstrual pattern was the major reason for discontinuation ranging between 42-43 per 100 users at the end of 24 months. Amongst these, amenorrhoea was the commonest reason for discontinuation. No change in blood pressure was observed during contraceptive usage. The majority of NET OEN users did not show any change in body weight. The overall continuation rates with NET OEN were lower than those observed in similar conditions with Cu-T 200 mm2 IUCD.

Indian council of medical research tubal sterilization with filshie clip

Abstract Female sterilization by the application of Filshe Clip Mark IV has been studied, on a prospective multicentric basis in 869 women for a period of two years. Sixty involuntary pregnancy following ligation were reported giving a failure rate of 8.6 per 100 women at the end of 24 months. Method failures were observed to be evenly distributed throughout the period of observation except in puerperal ligation in whom majority of the pregnancies occurred after six months following ligation. Failure rate was significantly higher in post-abortal ligations as compared to interval ligations. Due to unexpectedly higher failures rate further recruitment of study subjects was discontinued. Information on the status of the clip was available in only 30 of the sixty failures and the clips were in situ in only 4 cases, indicating improper application of clips. In view of high failure rates attributable to improper clip application, the method does not appear to be suitable for programmatic conditions in our country.

TWO YEARS EXPERIENCE WITH THE COPPER T 200 IN INDIA

Abstract A decade of international research has led to the development of copper IUDs. Reports have indicated lesser bleeding and pain and better acceptability with the TCu 200 device. Analysis of our data using life-table method on 4,357 women, over a period of 32,709 woman months, has given a net termination rate of 52.6 per 100 users at the end of two years. Pregnancy rate was 1.5 per 100 users, expulsion 9.4, removal for medical reasons 15.0, and removal for non-medical reasons 21.5. It is felt that better publicity and motivation may improve the overall acceptability of the TCu device by reducing removals for personal and other irrelevant reasons.

Clinical trial with the copper 7 intrauterine device — One year experience in India

Abstract Analysis of 12 months experience with the Cu7 (200 mm 2 ) device of 854 women for 5,177 woman months, using life-table methods, revealed a pregnancy rate of 2.4 per 100 users, expulsion-displacement 6.4, medical removals 11.4 and non-medical removals 9.2. Continuation rate at the end of one year was 70.6 per 100 users. No significant difference was noted on similar data obtained with the TCu 200 mm 2 device.

Return of fertility following discontinuation of an injectable contraceptive — Norethisterone oenanthate (NET EN) 200mg dose

Abstract The return of fertility following discontinuation of norethisterone oenanthate (NET EN) 200 mg injectable contraceptive after use for a minimum period of six months or more was studied in 69 women who discontinued the method for planning pregnancy. Former users of copper intra-uterine device (CuT 200) were enrolled as a control group. Another 161 women who had discontinued NET EN due to other reasons (e.g. amenorrhoea, excessive bleeding or personal reasons) were also studied for return of fertility after ensuring that they were not using any other method of contraception and were exposed to the risk of pregnancy. The subjects from both groups were followed for a period of one year. The cumulative conception rates at one year were 72.5 and 83.6 per 100 subjects for ex-NET EN and ex-CuT 200 users who had discontinued the method for planning pregnancy and this difference was not statistically significant (P > 0.05). The median time for conception for ex-NET EN users was 7.8 months as compared to 3.7 months in ex-CuT 200 users but the cumulative conception rates at the end of one year show that future return of fertility in NET EN users does not appear to be adversely affected. In 51 subjects who had discontinued NET EN due to amenorrhoea, the return of fertility was predictably slower and less. The return of fertility in subjects who discontinued NET EN for other reasons (e.g. excessive bleeding and other personal reasons) was similar to ex-NET EN and ex-CuT 200 users.

Phase II randomized comparative clinical trial of Norplant(R)∗∗ (six capsules) with Norplant(R)-2 (two covered rods) subdermal implants for long-term contraception: Report of a 24-month study

In a randomized clinical study, contraceptive efficacy and bleeding patterns were studied in a group of healthy, regularly menstruating, non-lactating women (n = 84) using two 4.4 cm covered silastic rods containing levonorgestrel, Norplant(R)-2, and compared with another group of women (n = 88) using six 3.4 cm capsules also containing levonorgestrel, Norplant(R). The silastic rods or capsules were placed subdermally in the medial aspect of the upper arm. No method failure was reported up to 24 months of use in this study with either of the device. The bleeding pattern was also similar for both devices as indicated by average episode length, number of bleeding runs and number of spotting days. The continuation rates with both devices were over 80 per 100 users at the end of 12 months and over 65 per 100 users at the end of 24 months. Discontinuations due to expulsion of the device, bleeding problems or personal reasons were few and similar for both devices. The results suggest that silastic-covered rods, Norplant(R)-2, which are comparatively easier to insert and remove and have similar clinical effect, could replace capsules, Norplant(R), as a long-term reversible subdermal contraceptive.

Immediate sequelae following tubal sterilization

Abstract A total of 32,177 female sterilizations performed by different surgical procedures under different time scales were studied with reference to the effectiveness of the procedure and immediate, short-term and longterm complications arising out of the procedure. The results of immediate sequelae only are being reported in this article. Laparoscopic technique was employed in 7.1% of cases, culdotomy in 6.9% and minilaparotomy/laparotomy in the remaining 86% of cases. The findings indicate that minilaparotomy performed in the postpartum period is most suitable and safe for Indian women under existing conditions. Complications including mortality were least when the operation was performed as a minilaparotomy in the early postpartum period. Visceral injuries were maximum with the laparoscopic technique (10.45/1000). Mortality of interval sterilization was higher than that of postpartum sterilization (6.19/10,000 Vs 0.7/10,000) but this rate is lower than the current maternal mortality of the country (41.76/10,000). In view of the results obtained, it appears that minilaparotomy will continue to be “the method” of choice on a mass scale.

Experience with 50 mcg and 75 mcg dl-norgestrel as a mini-pill in India.

Abstract Several reports have indicated the usefulness of a continuous dose mini-pill for fertility regulation. In this study, dl-norgestrel was given at two dose levels. Fifty mcg was given to 356 women for 1,665 woman months and 75 mcg to 312 women for 1,392 woman months. Data analyzed by life-table method showed that net cumulative rate for pregnancy at the end of 6 months was 3.4 with 50 mcg and 2.1 with 75 mcg. Breakthrough bleeding occurred more frequently with 75 mcg. Continuation rate with 50 mcg at 6 months was only 35.2 per 100 users. With 75 mcg, continuation rate was 24.2 per 100 users at 6 months, indicating the limited usefulness of the method for a national programme.

Clinical experience in India with a once-a-month oral contraceptive pill: Quingestanol and quinestrol

Abstract The results of several studies have shown favourable results with a once-a-month pill containing 2.5 mg quingestanol acetate and 2 mg quinestrol. In a multicentre study, 666 women were investigated for 3,130 woman months. Data analyzed using life-table method indicated a net cumulative continuation rate of only 15.0 per 100 users at the end of 12 months. Although the rate of discontinuing use of the pill for medical reasons was 42.2 per 100 users at 12 months, requests at the clinic for a “pill-a-month” method still continued. Further search for appropriate long-acting oral preparations is indicated for population groups included in this study.