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[A multicentre comparative clinical study of uterine cavity shaped device Cu300, TCu220C and TCu380A in ten years]

Author(s): Chen HP, Liu F, Wu SC, Zou MH, Tong ZJ, Song S, Cheng WY, Wang SZ, Pan QR

Affiliation(s): Affiliated Hospital, Chongqing Family Planning Scientific Research Institute, Chongqing 400020, China.

Publication date & source: 2003-05, Zhonghua Fu Chan Ke Za Zhi., 38(5):298-301.

Publication type: Clinical Trial; Comparative Study ; English Abstract; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: To observe the clinical effects of uterine cavity shaped device (UCD) Cu300, TCu220C and TCu380A in ten years. METHODS: Two thousand, six hundred and ninety-nine rural parous women were randomized into three groups. UCD Cu300 group had 899 cases, TCu220C group and TCu380A group each had 900 cases. Follow-up visits were performed at 3, 6, 12 months and 2, 3, 5, 10 years after insertion. RESULTS: The cumulative pregnancy rates in the 10th year for UCD Cu300, TCu220C and TCu380A were 2.56, 4.82, and 4.01 per 100 women, respectively. UCD Cu300 group was significantly lower than other two groups (P < 0.05). The expulsion rates were 4.54, 5.46 and 9.68 per 100 women, respectively. TCu380A was significantly higher than UCD Cu300 and TCu220C (P < 0.001). The rates of removal for bleeding and pain for UCDCu300, TCu220C and TCu380A were 6.71, 5.58 and 6.80 per 100 women, respectively, no statistical difference was shown. The cumulative continuation rates were 74.86, 66.22 and 63.56 per 100 women at the 10 th year, UCD Cu300 was the highest, TCu380A was the lowest (P < 0.01). CONCLUSIONS: UCD Cu300, TCu220C and TCu380A are effective for long-term contraception. They are worthy of wide spreading in rural areas.

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