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

Autor: Ying, Li, Su-min, Zhang, Feng, Chen, Chun-yan, Zhang, You-ping, Li, Jian, Zhou, Peng-cheng, Xun, Yang, Zhao, Lei, Ba, Li, Wang, Yu-lin, Wu, Jin-xun, Xu, Sen-quan, Yu, Li, Li, Yu-jun, Zhang, Guo-bin, Yu, Ai-hua, Fang, Jiang-tao, Huang, Ai-ping, Tian, He-ping, Chen
Rok vydání: 2012
Předmět:
Zdroj: Zhonghua yi xue za zhi. 91(45)
ISSN: 0376-2491
Popis: 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%) (P0.01). 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.
Databáze: OpenAIRE