Ramesh Amatya

A five-year clinical evaluation of NORPLANTR contraceptive subdermal implants in Bangladeshi acceptors

A non-comparative study of the Norplant contraceptive subdermal implant system was conducted in Dhaka, Bangladesh. The study was designed to evaluate the contraceptive efficacy, safety and overall acceptability of Norplant implants. Six hundred women were enrolled in the clinical trial, which began in 1985 at three study sites. Follow-up visits were scheduled at 1, 3, and 6 months after Norplant implant insertion, and every six months thereafter until removal or at the end of five years. There were no post-insertion pregnancies during Norplant implant use in this study. After five years of Norplant implant use, there was no clinically significant change in body weight, systolic or diastolic blood pressure. Less than 3% of the women ever reported having any significant medical problems such as migraine, respiratory or cardiac problems during the study. The gross cumulative continuation rate was 41.2 per 100 women at the end of five years. The two most frequently reported reasons for discontinuation during the study were menstrual problems and desired pregnancy. Of the women who completed the five-year user satisfaction questionnaire, the majority of the women (86.3%) planned to continue using contraception after study completion. Of these women, approximately one-third said they planned to use another Norplant set. The findings presented suggest that the Norplant system is a highly effective, safe and acceptable method among Bangladeshi women.

Complications and risk factors associated with the removal of norplant implants

Objective To describe the complications reported at the removal of Norplant implants, and to suggest potential risk factors for these complications. Methods Complications at the removal of Norplant implants from 3416 users from 11 countries who participated in preintroductory clinical trials of the method were tabulated. A logistic regression model was used to identify the significant risk factors associated with removal complications. Results Complications were reported in 4.5% of removals; most often, they were related to broken or deeply placed implants. The most important risk factors were complications at insertion and having an infection at the implant site (at or before removal). Conclusion Proper insertion technique under aseptic conditions is very important in predicting whether Norplant implant removal will be difficult. Although relatively infrequent even now, more vigilant training and the evaluation of some of the newer removal techniques could further reduce the incidence of difficult removals.

Two randomized controlled trials comparing the Tubal Ring and Filshie Clip for tubal sterilization

OBJECTIVE To compare the effectiveness and safety of the Filshie Clip and Tubal Ring systems when applied via minilaparotomy and laparoscopy. DESIGN Prospective, multicenter randomized controlled clinical trial, with postoperative evaluation by a physician who was masked to the operative technique. SETTING Healthy volunteers in a variety of hospital settings. PATIENT(S) 2746 women (915 in the minilaparotomy study and 1831 in the laparoscopy study) who had requested permanent surgical sterilization. INTERVENTION(S) Surgical tubal ligation, using either Filshie Clips or Tubal Rings. A physician other than the surgeon evaluated the patients after the operation and again at 1, 6, and 12 months after surgery. MAIN OUTCOME MEASURE(S) Pregnancy rates and safety-related events. RESULT(S) During the 12 months after surgery, two women who received the Filshie Clip and two women who received the Tubal Ring became pregnant, giving a 12-month life-table pregnancy probability of 1.7 per 1000 women in both groups. The Tubal Ring was more difficult to apply and had higher rates of tubal or mesosalpingeal injuries at surgery. The Filshie Clip group had three cases of spontaneous clip expulsion during the follow-up period. CONCLUSION(S) Both the Filshie Clip and Tubal Ring are effective and safe for use in tubal occlusion.

Contraceptive efficacy of the Copper T 380A and Copper T 200 intrauterine devices: results from a comparative clinical trial in six developing countries.

The clinical performance of the Copper T 380A (TCu 380A) and the Copper T 200 (TCu 200) intrauterine devices (IUDs) was evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a multicenter randomized clinical trial at one site in each of six developing countries. The pregnancy rate with the TCu 380A IUD was significantly lower than the pregnancy rate with the TCu 200 IUD at 12 months (0.5 and 2.6 per 100 women, respectively, p < 0.01). No statistically significant differences between the two study IUDs were found with regards to expulsion or removals due to bleeding/pain, personal, medical, or planned pregnancy. The TCu 380A IUD did not have a disproportionately higher incidence of side effects such as intermenstrual bleeding or pain, inflammations or infections, or insertion-related events compared to the TCu 200 IUD. TCu 380A IUD users, however, were significantly more likely to report increased dysmenorrhea than were TCu 200 IUD users. The performance of the TCu 380A IUD in preventing pregnancy during this trial indicates that this IUD may be a better option than the TCu 200 IUD for women wishing to practice effective, long-term, reversible birth control without having to resort to hormonal methods.

The effect of husband counseling on NORPLANT® contraceptive acceptability in Bangladesh

A pilot study of the effect of husband counseling on NORPLANT contraceptive acceptability was conducted at four family planning clinics in Bangladesh. The study objectives were to compare discontinuation rates and user satisfaction among acceptors whose husbands received counseling about the method versus those who did not. Of a total 617 subjects enrolled in the study which began in 1988, about two-thirds (408) of the husbands were counseled at admission or at the one-month follow-up visit while the remainder of the husbands (209) were not counseled. Follow-up visits were scheduled at one and six months after NORPLANT implants insertion, and every six months thereafter until the close of the study in 1991. Some evidence was found that counseling husbands of NORPLANT implants acceptors may reduce discontinuation rates. At the end of 36 months, a difference of 10 percentage points in total discontinuation rates was observed between the husband-counseled group (32 per 100 women) and the husband-not-counseled group (42 per 100 women). The husband counseling had the most impact at clinics with higher discontinuation rates. Based on Coxs proportional hazards regression model results, the hazard for discontinuation among the acceptors in the husband-not-counseled group. Satisfaction with NORPLANT implants did not differ between the two groups. Although these results are not striking, they do suggest a potential positive effect of husband counseling on NORPLANT contraceptive accept-ability. In future studies, the counseling of husbands should be more intensive and standardized.

Clinical performance of the TCu 380A and TCu 220C IUDs in four developing country family planning clinics.

The clinical performance of the Copper T 380A (TCu 380A) and the Copper T 220C (TCu 220C) intrauterine devices (IUDs) were evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at four collaborating research sites located in two developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the TCu 220C IUD at 12 months (0.3 and 0.8, respectively), although this difference was not statistically significant (p > 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, personal reasons, medical reasons, or planned pregnancy. No statistically significant differences were observed in the frequency of experiencing menstrual disturbances (i.e., dysmenorrhea, intermenstrual pelvic pain or intermenstrual bleeding) between the two IUD groups. These data suggest that the TCu 380A and TCu 220C IUDs are both appropriate options for contracepting women. The TCu 380A IUD, however, may be a more appropriate option for those women wishing to space births over a longer period of time.

Twelve-month comparative multicenter study of the TCu 380A and ML 250 intrauterine devices in Bangkok, Thailand

The long-term effectiveness of the copper-bearing intrauterine device (IUD) has been documented. This paper reports 12-month results from a multiyear comparative study of the Copper T (TCu) 380A and Multiload (ML) 250 IUD in Bangkok, Thailand, among 1396 women. Continuation of the assigned IUD was relatively high after 12 months of use, with continuation rates of 90.17 and 87.54 per 100 women, respectively. Whereas the accidental pregnancy rate was higher for the ML 250 IUD than for the TCu 380A IUD (1.0 and 0.2 per 100 women, respectively), this difference was not considered statistically significant (p < 0.69). The rate of IUD expulsion was significantly higher among women using the ML 250 IUD than for women using the TCu 380A IUD (4.61 and 2.40 per 100 women, respectively, p = 0.05).

Norplant Implants Acceptability and User Satisfaction Among Women in Two African Countries

An analysis of 350 users of Norplant contraceptive subdermal implants from six centers in two African countries (Ghana and Nigeria) indicates that method acceptability remained high among the women who used the method for five years. Overall, 90.1% of the 155 five-year users in these countries reported having a very favorable experience and 9.9% a favorable experience with Norplant implants. Ease of use was cited by 56.1% and duration of use by 13.6% of the women as the most liked characteristics of the method at study completion after five years. Menstrual disturbance was the least liked aspect, by 41.9% of the women. On average, women who discontinued early from the study had fewer living children and were more likely to desire additional children at method adoption than those who completed five years of use; the differences were statistically significant. Differences in level of education and previous use of contraception were not found to be statistically significant between completers and non-completers. Differences in age were not significant in Nigeria, but were marginally significant in Ghana, with completers being older than non-completers. Of the clients who completed this study, 79.2% indicated a desire to continue with contraception and 43.9% planned to have a second set of implants inserted. These findings have important implications for counseling, method access and service sustainability in African countries.

Norplant® contraceptive acceptability among women in five Asian countries

An analysis of 1,882 Asian acceptors of Norplant implants indicates that method acceptability remained high among the 882 women who used the method for five years. Women who discontinued early from the study were, on average, younger than those who completed five years of use. Also, they had fewer live births and were more likely to desire additional children. Overall, about 70% of the women in these countries found the Norplant implant method to be very favorable. The majority (> 40%) of the women found the ease and duration of use of the method to be most attractive, while menstrual disturbances were the least-liked aspect of the method. Although it was apparent that there are still some potential obstacles to Norplant implant acceptance, most noticeably concerns about menstrual irregularities, interest in continuing the method after five years of use is high. Further research of issues related to Norplant implant acceptability may improve continuation rates and overall client satisfaction.

Clinical performance of the TCu 380A and Lippes Loop IUDs in three developing countries

The clinical performance of the Copper T 380A (TCu 380A) and the Lippes Loop intrauterine devices (IUDs) were evaluated for 12 months in a group of 710 women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at three collaborating research sites located in three developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the Lippes Loop IUD at 12 months (0.7 and 2.1 per women, respectively). Although this difference was not statistically significant (p = 0.25), it is similar to findings from other studies. The 12-month cumulative removal rate due to personal reasons was significantly different (1.4 and 0.0, respectively, p = 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, medical reasons, planned pregnancy or investigators choice. A statistically significant difference (p = 0.03) was observed in the number of TCu 380A IUD users experiencing dysmenorrhea (26.1%) during the 12-month study period, compared to Lippes Loop IUD users (18.8%).