A randomized clinical trial of intrauterine device MYCu / 中华全科医师杂志

ABSTRACT

Objective To observe safety and efficacy of intrauterine device MYCu IUD that releases indomethacin. Methods In total, 2000 women requiring IUD for contraception were chosen from domestic multiple clinical centers according to an unified standard. MYCu IUD and TCu380A IUD were randomly inserted for 1000 women each, respectively. All women were regularly followed-up one, three, six and 12 months after insertion. Results All the women were followed-up for 11 985.9 and 11 753.6 person-months in MYCu IUD and TCu380A IUD groups, respectively, with cumulative IUD application rates of 97. 80% and 94. 70%, and cumulative pregnancy rates with IUD of 0. 10% and 0. 31%, respectively. Cumulative expulsion (or partial expulsion) rate in MYCu IUD group was 0. 10%, significantly lower than that in TCu380A IUD one (1.73%), P ＜0. 01, and cumulative removal rate due to medical reasons (bleeding or pain) was 1.51 % and 2. 94%, respectively, P ＜ 0. 05. Rate of IUD-associated termination and overall rate of termination differed significantly between the two groups, P ＜0. 01. Adverse reactions one, three, six and twelve months after IUD insertion included irregular bleeding, prolonged menstruation, increased menstrual blood volume and pain, less in indomethacin-containing MYCu IUD group than those in TCu380A IUD without containing it, P ＜ 0. 01. Conclusions MYCu IUD is a comparatively ideal IUD that should be promoted for extensive use, with extremely low expulsion rate, good contraceptive effect, convenience and safety in insertion and removal, and less adverse effects.