A multi-center randomized controlled trial of intrauterine device use in Chinese women
Li, Y.; Zhang, S.-m.; Chen, F.; Zhang, C.-y.; Li, Y.-p.; Zhou, J.; Xun, P.-c.; Zhao, Y.; Ba, L.; Wang, L.; Wu, Y.-l.; Xu, J.-x.; Yu, S.-q.; Li, L.; Zhang, Y.-j.; Yu, G.-b.; Fang, A.-h.; Huang, J.-t.; Tian, A.-p.; Chen, H.-p.
Zhonghua Yi Xue Za Zhi 91(45): 3172-3175
2011
ISSN/ISBN: 0376-2491 PMID: 22333096 Document Number: 565136
To assess the safety and effectiveness of intrauterine device in Chinese women. 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. 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. The newly developed indomethacin-releasing YCu365 IUD appears to perform the best. However, its long-term safety and cost-effectiveness should be further evaluated.