A five-year international study of users of Norplant® implants in eight developing countries "confirms the safety with respect to serious disease and the high contraceptive efficacy" of the method, the United Nations World Health Organization (WHO) announced over the weekend.
In a statement issued at its Geneva headquarters on Saturday, WHO said the post-marketing study compared 8,000 Norplant users with 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 concluded that Norplant was "not associated with any material risk of major morbidity compared with the two control groups." The study was carried out by experts from the Special Programme of Research, Development and Research Training in Human Reproduction (HRP) -- a joint effort by the World Bank, the UN Population Fund, the UN Development Programme and the World Health Organization - and the Population Council, a New York-based international nongovernmental organization that seeks to improve reproductive health through biomedical, social science, and public health research.
"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," said Dr. Paul Van Look, Director of WHO's Department of Reproductive Health and Research. "The post-marketing surveillance also showed the feasibility of conducting large multi-centre studies in developing countries."
The study, which is the first prospective post-registration surveillance of a newly introduced contraceptive in developing countries, appears in the 1 April issue of Obstetrics & Gynecology. Complete details of the methods and results of the study will be published shortly in the journal Contraception. The countries involved in the survey were Bangladesh, Chile, China, Colombia, Egypt, Indonesia, Sri Lanka, and Thailand.
The Special Programme of Research, Development and Research Training in Human Reproduction was established by WHO in 1972. It coordinates, promotes, conducts and evaluates international research in reproductive health.