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Title: Immediate postplacental insertion of GYNE-T 380 and GYNE-T 380 postpartum intrauterine contraceptive devices: randomized study.
Author: Tatum HJ, Beltran RS, Ramos R, Van Kets H, Sivin I, Schmidt FH.
Journal: Am J Obstet Gynecol; 1996 Nov; 175(5):1231-5. PubMed ID: 8942493.
Abstract:
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. In clinics in Belgium, Chile, and the Philippines, data on 300 healthy, sexually active acceptors of the GYNE- T 380 IUD were compared with data on 292 healthy, sexually active acceptors of the GYNE-T 380 Postpartum IUD in order to compare the 10-year expulsion and efficacy rates of these 2 IUDs when inserted within 10 minutes of delivery of the placenta in a term pregnancy. The IUDs were identical, except that the GYNE-T 380 Postpartum IUD was inserted by a temporary fundal suspension system, while the GYNE-T 380 IUD was inserted directly into the uterus. No perforations occurred. The minimal complications that did occur were the same as those associated with interval IUD insertion: irregular spotting, menorrhagia, and uterine cramping. The rates for IUD discontinuation due to bleeding or pain and for other medical reasons were the same for both copper- releasing IUDs (3%). The removal rate for other medical reasons was less than 1% for each IUD. The only intrauterine pregnancy occurred in a woman using the nonsuspended, standard GYNE-T 380 IUD. The IUD continuation rate was greater than 80% for each IUD. Within each clinic, no statistically significant difference in the IUD expulsion rate existed at any time during the 12-month study period. Overall, the expulsion rates for the 2 IUDs were similar (e.g., at 12 months, 16.2% for GYNE-T 380 Postpartum IUD and 13.2% for GYNE-T 380 IUD). The Philippine clinic had significantly higher 1-year IUD expulsion rates regardless of IUD type than the Chilean clinic (24-32% vs. 5-6%). The Belgian clinic had moderately high 1-year IUD expulsion rates regardless of IUD type (8-16%). The different expulsion rates between clinics suggest differences in techniques used during insertion. These findings show that both IUD types inserted immediately after placental delivery are safe and acceptable. If the techniques associated with the low expulsion rates in Chile can be taught, these IUDs can be a practical, safe, convenient, and acceptable contraceptive method.

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