IMMEDIATE POSTPLACENTAL INSERTION OF GYNE-T-380 AND GYNE-T-380 POSTPARTUM INTRAUTERINE CONTRACEPTIVE DEVICES - RANDOMIZED STUDY

OBJECTIVE: The purpose of the investigation was to compare the 1-year expulsion and efficacy rates of the GYNE-T 380 and the GYNE-T 380 Post partum intrauterine contraceptive devices when inserted within 10 minu tes after expulsion of the placenta in a term pregnancy. The two intra uterine contraceptive devices were identical, except that one was inse rted by means of a temporary fundal suspension system and the other wa s placed directly into the uterine cavity. STUDY DESIGN: The study was a multicenter, randomized trial of intrauterine contraceptive devices in which 300 subjects accepted the GYNE-T 380 IUD and 292 subjects th e GYNE-T 380 Postpartum IUD in clinics with adequate follow-up. RESULT S: At 1 year the gross cumulative expulsion rate was 13.2 per 100 case s (39 expulsions) with the GYNE-T 380 intrauterine contraceptive devic e and 16.2 per 100 cases (46 expulsions) with the GYNE-T 380 Postpartu m device. There was no significant difference in the rate of expulsion between the two devices at any time during the year. There was one fi rst-year intrauterine pregnancy, which occurred in a subject using the GYNE-T 380 device. The continuation rate for each device was above 80 per 100. CONCLUSION: The results indicate that both the GYNE-T 380 Po stpartum and the standard GYNE-T 380 intrauterine contraceptive device s are safe and effective when inserted immediately after delivery of t he placenta.