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 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.


METHODS
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.


CONCLUSIONS
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.
Tatum
H J
HJ
Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, Georgia, USA.
Beltran
R S
RS
Ramos
R
R
Van Kets
H
H
Sivin
I
I
Schmidt
F H
FH
D005260:Female; D006801:Humans; D007434:Intrauterine Devices; D049590:Postpartum Period; D011247:Pregnancy