Five-year evaluation of safety, efficacy and acceptability of Norplant implants in Nepal.

Abstract

This paper presents findings based on a five-year, noncomparative study of Norplant contraceptive subdermal implants in Nepal. The study was designed to evaluate the contraceptive safety, efficacy, and overall acceptability of Norplant. Four hundred and seven women enrolled in the clinical trial, which began in 1985, at two study sites, located in Patan and Kathmandu. Follow-up visits were scheduled at 1, 3 and 6 months after Norplant insertion and every six months thereafter until removal or at the end of five years. Although five pregnancies were reported during the study, only two women (one from each center) were diagnosed as becoming pregnant while using Norplant. The pooled gross cumulative life-table pregnancy rate was 0.6 per 100 women at the end of five years. The pooled cumulative continuation rate was 62 per 100 women at the end of five years. The three most frequently reported reasons for discontinuation were menstrual problems, personal reasons, and medical reasons. Of the 125 women who completed a five-year user satisfaction questionnaire, the majority of the women (86%) planned to continue using contraception after study completion. Of these women, almost one half said they planned to use a second Norplant set. The findings suggest that the Norplant system is a safe, effective, and acceptable method of contraception among Nepalese women.