Clinical experience with the GYNE-T 380 postpartum intrauterine device.

Objective: The insertion of conventional intrauterine devices (IUDs) during the 1st 10 days after delivery is associated with a high rate of expulsions.

Design: The GYNE-T 380 (Ortho Pharmaceutical [Canada] Ltd., Toronto, Ontario, Canada) IUD was modified by the addition of a loose loop of knotted biodegradable no. 2 catgut to the top of the IUD (GYNE-T 380 postpartum IUD). After delivery, a special inserter was used to imbed the knotted portion of the loop into the myometrium of the uterine fundus.

Patients, Participants: This modified IUD was evaluated in a phase II trial involving 190 women at four clinical sites.

Main Outcome Measures: There were no pregnancies during the 1st year of the study. The continuation rate was 74 per 100 women and a life table expulsion rate of 9.6 and 13.3 per 100 women was observed at 6 and 12 months, respectively.

Results: Complications associated with the insertion and the use of this IUD were minimal. Large scale trials evaluating this IUD are in progress.