Study Finds Norplant As Safe And Effective As IUD And Sterilization.

2001 APR 12 - (NewsRx.com & NewsRx.net) -- A five-year international postmarketing surveillance of users of the [Norplant.sup.R] implant in eight developing countries "confirms the safety with respect to serious disease and the high contraceptive efficacy" of the method, according to a study in the April 2001 issue of Obstetrics & Gynecology.

The study compared some 8,000 Norplant users with about 8,000 women who relied either on an intrauterine device (IUD) or sterilization to determine the safety of these methods in developing-country settings and assess the risk of rare adverse events that may not have been identified earlier in clinical trials.

Researchers from the UNDP/UNFPA/WHO/World Bank Special Program of Research, Development and Research Training in Human Reproduction (HRP), and the Population Council conclude that Norplant is "not associated with any material risk of major morbidity compared with the two control groups."

This study is the first prospective postregistration surveillance of a newly introduced contraceptive in developing countries. The principal authors are Olav Meirik, formerly at the World Health Organization (WHO), Timothy M.M. Farley, WHO, and Irving Sivin, Population Council. Complete details of the methods and results of the study will be published shortly in the journal Contraception.

Dr. Paul Van Look, director of the Department of Reproductive Health and Research at WHO, said, "The study demonstrates that all three methods are very safe and provide excellent long-term protection against unplanned pregnancy and considerably reduce the risk of ectopic pregnancy." The postmarketing surveillance, he said, also showed the feasibility of conducting large multicenter cohort studies in developing countries.

Involving investigators at 32 family planning clinics in eight developing countries (Bangladesh, Chile, China, Colombia, Egypt, Indonesia, Sri Lanka, and Thailand), the study followed 7,977 Norplant users, 6,625 users of copper-bearing or non-copper IUDs, and 1,419 women who had been sterilized. Women were enrolled from 1987 to 1991 and were followed for five years, even if they discontinued use of the method, switched to another method, or became pregnant. The women made regular visits to the study clinics every six months, reported any health problems, and kept diaries of contacts with other health providers and facilities. The follow-up was completed in 1997, with over 78,323 woman-years of observation. Ninety-five percent of the women enrolled remained in the study and were accounted for at the end of the five-year follow-up period. The annual method continuation rates for both Norplant and IUD users averaged more than 90 per 100 women.

All complaints, symptoms, and diseases were recorded and classified either as a "major health event" or an "other health problem." Major health events were potentially life-threatening problems that required hospitalization, convalescence of at least one month, or medication for three months or more, left sequelae, or led to death.