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Title: A five-year clinical evaluation of Norplant contraceptive subdermal implants in Bangladeshi acceptors.
Author: Akhter H, Dunson TR, Amatya RN, Begum K, Chowdhury T, Dighe N, Krueger SL, Rahman S.
Journal: Contraception; 1993 Jun; 47(6):569-82. PubMed ID: 8334891.
Abstract:
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. From February 1985 to February 1986, researchers enrolled 600 18-40 year old women at the Dhaka Medical College and Hospital, the Institute of Postgraduate Medicine and Research, and the Mohammadpur Fertility Services and Training Centre in a 5-year clinical trial to evaluate the contraceptive efficacy, safety, and acceptability of Norplant subdermal implants in Bangladesh. They scheduled the women to return for follow-up visits 1, 3, and 6 months after insertion and every 6 months thereafter until removal or at the end of 5 years. No pregnancies after insertion occurred during the study. The gross cumulative continuation rate was 93.9% at 1 year and 72.3% at 2 years. The 5-year cumulative continuation rate was 41.2% which was much lower than that in other Asian countries (e.g., 52.3% in Sri Lanka and 78.2% in Indonesia). The 5-year cumulative discontinuation rate for menstrual problems was 30.7% which was higher than that of other studies. It may have been higher because Bangladeshi women do not tolerate well and accept changes in bleeding patterns, especially since menstrual bleeding prevents them from prayer and taking part in sexual activity. 45.3% of all women requesting early Norplant removal complained of menstrual problems, especially prolonged heavy bleeding (75% of women requesting removal for menstrual problems). Most menstrual problem removals took place during the 2nd year and fell thereafter. Desired pregnancy was the second most common reason for removal (18.6%). The gross discontinuation rate for nonmenstrual side effects was just 2.2%, the main side effect being headaches. 97.5% of women who completed the 5-year study considered their experience with Norplant favorable. The leading reason for a favorable rating for Norplant was its duration of use (64.5%). Menstrual changes comprised the least favorable component of Norplant among women who completed the study (63.3%). 33% of women still wanting to use contraception after 5 years of Norplant use said they would use Norplant again.

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