A comparative clinical trial of the TCu 380A, Lippes Loop D and Multiload Cu 375 IUDs in Indonesia.
The Copper T 380A (TCu 380A), Lippes Loop D (LLD) and the Multiload Cu 375 (MLCu 375) IUDs were evaluated for safety and efficacy in a multicenter randomized clinical trial in Indonesia. A total of 2992 women were enrolled into the study and data for 2845 women were analyzed (147 cases did not meet protocol criteria). Although study IUDs were randomly assigned, LLD users in this study were older and of higher parity than TCu 380A and MLCu 375 users. The 24-month gross cumulative life-table pregnancy rates for TCu 380A, LLD and MLCu 375 users were 1.2, 2.2 and 2.7, respectively. The 24-month expulsion rates for TCu 380A, LLD and MLCu 375 users were 6.7, 7.5 and 5.3, respectively. Overall, 24-month continuation rates were 85.5%, 85.0% and 85.4% for the respective device groups. Differences in both gross and age- and parity-adjusted life-tables rates for the major outcome variables were not statistically significant at 24 months postinsertion. The study suggests that the TCu 380A, LLD and MLCu 375 IUDs seem to be safe and effective contraceptive options for Indonesian women.
Sastrawinata
S
S
Coordinating Board of Indonesian Fertility Research (BKS PENFIN), Bandung.
Farr
G
G
Prihadi
S M
SM
Hutapea
H
H
Anwar
M
M
Wahyudi
I
I
Sunjoto
Kemara
K P
KP
Champion
C B
CB
Robbins
M
M
D000293:Adolescent; D000328:Adult; D004412:Dysmenorrhea / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007214:Indonesia; D007231:Infant, Newborn; D007416:Intestinal Perforation / Q000209:etiology; D007433:Intrauterine Device Expulsion; D007434:Intrauterine Devices; D007435:Intrauterine Devices, Copper; D015993:Life Tables; D010146:Pain / Q000209:etiology; D011247:Pregnancy; D014599:Uterus / Q000293:injuries