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.


METHODS
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.


METHODS
This modified IUD was evaluated in a phase II trial involving 190 women at four clinical sites.


METHODS
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.
Van Kets
H
H
University of Ghent, Belgium.
Kleinhout
J
J
Osler
M
M
Parewijck
W
W
Zighelboim
I
I
Tatum
H J
HJ
D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007434:Intrauterine Devices; D007743:Labor, Obstetric; D015993:Life Tables; D049590:Postpartum Period; D011247:Pregnancy