RESUMO
The clinical performance of the Copper T 380A (TCu 380A) and the Lippes Loop intrauterine devices (IUDs) were evaluated for 12 months in a group of 710 women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at three collaborating research sites located in three developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the Lippes Loop IUD at 12 months (0.7 and 2.1 per women, respectively). Although this difference was not statistically significant (p = 0.25), it is similar to findings from other studies. The 12-month cumulative removal rate due to personal reasons was significantly different (1.4 and 0.0, respectively, p = 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, medical reasons, planned pregnancy or investigator's choice. A statistically significant difference (p = 0.03) was observed in the number of TCu 380A IUD users experiencing dysmenorrhea (26.1%) during the 12-month study period, compared to Lippes Loop IUD users (18.8%).
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.