| 1. Peer Reviewed Title: Post-marketing surveillance of Norplant contraceptive implants: I. Contraceptive efficacy and reproductive health. International Collaborative Post-Marking Surveillance. Author: Meirik O; Farley TM; Sivin I; Diaz S Source: Contraception. 2001 Apr;63(4):167-86. Abstract: To examine the safety and contraceptive efficacy of Norplant, the authors undertook a 5-year follow-up study of women using Norplant, an IUD, or sterilization in 8 developing countries. Women attending family clinics were enrolled if they consented and were medically eligible for Norplant, an IUD, or female sterilization. Women who chose to use an IUD or resorted to surgical sterilization served as controls and were frequently matched in 5-year age bands with women who chose to use Norplant. At admission women had a physical examination, and their medical histories, demographic, and socioeconomic characteristics were recorded. Follow-up visits were scheduled in the first 6 weeks after admission and semi-annually thereafter for 5 years irrespective of change of contraceptive method. Incidence rate ratios of health events were estimated for initial and current contraceptive method use. This paper reports reproductive health events and contraceptive efficacy. Altogether, 7977 women initiating use of Norplant, 6625 of IUD, and 1419 of surgical sterilization were admitted. Their mean ages at initiation were 28.5, 28.5, and 29.6 years, respectively. More than 99% were married or cohabiting, and parous. 5-year follow-up was completed by 94.6% of the women. By the end of 5 years, the mean duration of first segment use per initiator was 4.16 years for Norplant, 4.10 years for IUDs, and 4.96 years for sterilization accounting for 39,337 woman-years for Norplant, 31,915 for IUDs, and 7071 for sterilization. The study accumulated 78,323 woman-years of observation. Pearl pregnancy rates for Norplant, copper IUDs, and female sterilization were 0.27, 0.88, and 0.17 per 100 woman-years, respectively. Users of Norplant, copper IUDs, and sterilization had rates of ectopic pregnancy of 0.30, 0.68, and 0.13 per 1000 woman-years, respectively. Major health events related to the reproductive system were rare. Rates of acute pelvic inflammatory disease were significantly lower among Norplant users than IUD users (p = 0.004). The rate of ovarian enlargement was significantly higher in Norplant users than controls (p < 0.001), but not rates of hospitalization for this condition. Vaginitis and vaginal discharge, and low abdominal pain were significantly less frequent in Norplant users that in the other groups. Bleeding disturbances were more frequent among Norplant users than controls but not anemia. The study confirms the high contraceptive efficacy of Norplant, copper IUDs, and female sterilization. The incidence rates of major reproductive health problems were low. There was no significant excess of serious reproductive morbidity among users of Norplant compared to users of IUDs and sterilization. (author's, modified) Language: English Keywords: DEVELOPING COUNTRIES | RESEARCH REPORT | COHORT ANALYSIS | FOLLOW-UP STUDIES | CONTRACEPTIVE EFFECTIVENESS | SAFETY | REPRODUCTIVE HEALTH | CONTRACEPTIVE IMPLANTS | LEVONORGESTREL | IUD, COPPER RELEASING | FEMALE STERILIZATION | Research Methodology | Studies | Contraception | Family Planning | Public Health | Health | Contraceptive Methods | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | IUD | Sterilization, Sexual Document Number: 157867 |
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