Akhter H, Dunson T R, Amatya R N, Begum K, Chowdhury T, Dighe N, Krueger S L, Rahman S
Bangladesh Institute of Research for Promotion of Essential & Reproductive Health and Technologies, Dhaka.
Contraception. 1993 Jun;47(6):569-82. doi: 10.1016/0010-7824(93)90024-2.
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.
在孟加拉国达卡对诺普兰皮下植入避孕系统进行了一项非对照研究。该研究旨在评估诺普兰植入剂的避孕效果、安全性和总体可接受性。600名女性参与了这项临床试验，该试验于1985年在三个研究地点开始。在植入诺普兰后1个月、3个月和6个月安排随访，此后每六个月随访一次，直至取出或五年结束。在本研究中，使用诺普兰植入剂期间未发生植入后妊娠。使用诺普兰植入剂五年后，体重、收缩压或舒张压没有临床上的显著变化。在研究期间，不到3%的女性曾报告有任何重大医疗问题，如偏头痛、呼吸或心脏问题。五年结束时，总累积持续率为每100名女性中有41.2人。研究期间最常报告的两个停药原因是月经问题和想要怀孕。在完成五年用户满意度问卷的女性中，大多数女性（86.3%）计划在研究结束后继续使用避孕方法。在这些女性中，约三分之一表示计划使用另一套诺普兰。研究结果表明，诺普兰系统在孟加拉国女性中是一种高效、安全且可接受的方法。
