OBJECTIVES. The purpose of the study was to determine the contraceptive efficacy of the female condom and to provide data about the device to the US Food and Drug Administration. METHODS. The clinical trial was conducted at six US sites and three sites in Latin America. Eligible subjects were in mutually monogamous relationships and agreed to use the female condom as their only means of contraception for 6 months. RESULTS. A total of 328 subjects contributed to the analysis of contraceptive efficacy. Twenty-two US subjects and 17 Latin American subjects became pregnant, yielding 6-month gross cumulative accidental pregnancy rates of 12.4 and 22.2, respectively. During perfect (consistent and correct) use of the method, the 6-month accidental pregnancy rates were 2.6 and 9.5 for the US and Latin American centers, respectively. There were no serious adverse events related to the use of the method. CONCLUSIONS. The female condom provides contraceptive efficacy in the same range as other barrier methods, particularly when used consistently and correctly, and has the added advantage of helping protect against sexually transmitted diseases.

Postpartum insertion of intrauterine contraceptive devices (IUDs) performed while women are still in hospital has a number of advantages. Earlier reports, however, generally associated this procedure with high expulsion rates. Recent studies, on the other hand, have shown that if IUDs are inserted immediately (within 10 minutes) after placental delivery, it is safe and effective. In some experienced centers, fairly low expulsion rates are reported. In this paper the experiences with postplacental IUD insertions from international studies are reviewed, the lessons we have learned from these experiences summarized, and future research directions suggested.

It is believed that much of the small increased risk for developing pelvic inflammatory disease (PID) associated with the use of an intrauterine device (IUD) appears to be caused by bacterial contamination of the endometrial cavity at the time of insertion. Previous research suggests that use of prophylactic antibiotics immediately prior to IUD insertion may reduce the risk of developing PID. This paper presents results from a randomized clinical trial of 1485 women in Ibadan, Nigeria evaluating the effectiveness of 200 mg of doxycycline (versus placebo) given orally at the time of IUD insertion in reducing the incidence of PID during the first three months of IUD use. Rate of PID infection in the doxycycline-treated group was not significantly lower than that in the placebo-treated group. The rate of unscheduled IUD-related visits to the clinic also was not significantly lower among the doxycycline-treated group. However, the incidence of PID was low (21 cases) for both study groups. Aseptic conditions during IUD insertion, follow-up visits with short intervals to monitor health, and treatment of opportunistic infections may have reduced the potential of PID within this population.