Clinical performance of the TCu 380A and Lippes Loop IUDs in three developing countries.

ABSTRACT

PIP: A randomized clinical trial conducted at collaborating research sites in Peru, Nigeria, and Turkey found no significant differences between the performance of the Copper T 380A (TCu 380A) IUD and the Lippes Loop at 12 months post-insertion. The Lippes Loop is one of the few unmedicated IUDs still in use in developing countries, while the TCu 380A is steadily gaining in favor because of its longer effective life-span. Included in the analysis were 356 TCu 380A acceptors and 354 Lippes Loop users. The accidental pregnancy rate was 0.7/100 women-months of exposure for the TCu 380A and 2.1/100 for the Lippes Loop (p = 0.25); the expulsion rates were 3.5% and 6.7%, respectively, and the discontinuation rates were 15.6% and 15.8%, respectively. More women in the TCu 380A group (18.8%) than in the Lippes Loop group (14.3%) reported genitourinary tract infection during the 12-month study period, but this difference was not significant (p = 0.15). In addition, a nonsignificantly greater number of women in the former group (36.9%) than the latter group (31.8%) experienced dysmenorrhea, intermenstrual bleeding, or intermenstrual pelvic pain (p = 0.20). These findings are generally consistent with previous research.