American journal of obstetrics and gynecology · 1996
Immediate postplacental insertion of GYNE-T 380 and GYNE-T 380 postpartum intrauterine contraceptive devices: randomized study.
Клиническое исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Tatum H J, Beltran R S, Ramos R, Van Kets H, Sivin I, Schmidt F H
Аннотация
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 Postpartum intrauterine contraceptive devices when inserted within 10 minutes after expulsion of the placenta in a term pregnancy. The two intrauterine contraceptive devices were identical, except that one was inserted by means of a temporary fundal suspension system and the other was 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 the GYNE-T 380 Postpartum IUD in clinics with adequate follow-up.
RESULTS: At 1 year the gross cumulative expulsion rate was 13.2 per 100 cases (39 expulsions) with the GYNE-T 380 intrauterine contraceptive device and 16.2 per 100 cases (46 expulsions) with the GYNE-T 380 Postpartum device. There was no significant difference in the rate of expulsion between the two devices at any time during the year. There was one first-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 Postpartum and the standard GYNE-T 380 intrauterine contraceptive devices are safe and effective when inserted immediately after delivery of the placenta.
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 the GYNE-T 380 Postpartum IUD in clinics with adequate follow-up.
RESULTS: At 1 year the gross cumulative expulsion rate was 13.2 per 100 cases (39 expulsions) with the GYNE-T 380 intrauterine contraceptive device and 16.2 per 100 cases (46 expulsions) with the GYNE-T 380 Postpartum device. There was no significant difference in the rate of expulsion between the two devices at any time during the year. There was one first-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 Postpartum and the standard GYNE-T 380 intrauterine contraceptive devices are safe and effective when inserted immediately after delivery of the placenta.