[A multi-center randomized controlled trial of intrauterine device use in Chinese women].

OBJECTIVE: To assess the safety and effectiveness of intrauterine device in Chinese women. METHODS: In this multicenter randomized controlled trial a total of 24 000 women were randomly (1:1:1) into 3 groups of Yuangong Cu 365 (YCu365) Copper T 380A (TCu380A) and Multiload Cu 375 (MLCu375). Clinical outcomes were assessed at 12 months post-insertion including discontinuation due to pregnancy expulsion hemorrhage and downward displacement etc. The overall and causal-specific discontinuation rates for adverse events were calculated. RESULTS: At the end of the first year the discontinuation rate of YCu365 (4.21%) was the lowest followed by TCu380A (8.42%) and MLCu375 (13.91%) (P < 0.01). The differences of discontinuation rates for pregnancy expulsion hemorrhage and downward displacement between these IUDs were also significant. MLCu375 side effect without medical treatment fewer follow-ups deeper uterine cavity and previous IUD failure were significantly associated with an increased risk of IUD discontinuation. CONCLUSION: The newly developed indomethacin-releasing YCu365 IUD appears to perform the best. However its long-term safety and cost-effectiveness should be further evaluated.