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[A multi-center randomized controlled trial of intrauterine device use in Chinese women]
Ying Li1, Su-min Zhang, Feng Chen
1Jiangsu Institute of Planned Parenthood Research, Nanjing, China. liying2008@jsmail.com.cn
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.
