A comparative study of the TCu 380A versus TCu 200 IUDs in Nepal.

As part of a multinational trial this study compared the safety and efficacy of the TCu 200 IUD with the locally used TCu 200 IUD at the Maternity Hospital in Thapathali Kathmandu Nepal with 24 months of subject follow-up. 200 subjects were enrolled over a 7-month enrollment period beginning in November 1981. By random allocation 100 subjects received the TCu 380A IUD and 100 subjects received the TCu 200 IUD. All subjects had the IUDs inserted 6 weeks or more after the end of their last pregnancy. The mean age was 23.1 years for the TCu 380 IUD group and 23.5 years for the TCu 200 IUD group. All subjects in each IUD study group had at least 1 live birth prior to admission into the study and the overall mean was similar for both study groups. The only insertion-related complaint reported was mild pelvic pain: in 16.0% of the women receiving the TCu 380A and 19.0% of those receiving the TCu; this difference was not statistically significant. Menorrhagia was reported in both the TCu 380A and TCu 200 IUD groups (3% and 5% respectively). Intermenstrual pelvic pain spotting and bleeding were also reported although the proportion of subjects in either study group experiencing these complaints did not exceed 7%. One case of pelvic inflammatory disease i.e. endometritis in a TCu 200 IUD user was reported but no cases were reported among TCu 380A users. One case of a mucoid vaginal discharge was reported in each IUD study group. Significantly more TCu 200 IUD users (p = 0.02) experienced removal of their IUD during the 24-month follow-up period for personal reasons than did TCu 380A IUD users (6.7 and 1.2 per 100 women respectively; p = 0.02). The overall continuation rate at 24 months was higher for TCu 380A IUD users than for TCu 200 IUD users (82.8 and 14.9 per 100 women respectively) although this difference was not statistically significant (p = 0.18).