Zhonghua fu chan ke za zhi · 2010
[A multi-center randomized controlled trial of three types of intrauterine device inserted immediately after vacuum aspiration].
Сравнительное исследованиеАннотация на английскомСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Research Group on Failure Causes and Prevention Measures of Intrauterine Device
Аннотация
OBJECTIVE: To compare the safety and effectiveness of three types intrauterine device (IUD) insertion immediately after vacuum aspiration, and to provide evidence for women fulfilling contraception and reducing repeat abortion.
METHODS: A multi-center randomized controlled clinical trial was performed in 12 medical institutions or family planning service stations located in China. Total 1800 eligible women were inserted G-Cu200, TCu380A or active γ-IUD randomly after vacuum aspiration immediately, and they were followed up for 12 months.
RESULTS: Except for 2 cases who dropped out (loss rate is 0.11%, 2/1800) and 17 cases who didn't match the including standard, the data of 1781 cases was analyzed. No any uterine perforation or ectopic IUD was found. During followed up 12 months, there was also no any pregnancy or pregnancy with IUD in situ occurred in the three groups. The medical removal rate for bleeding or (and) pain of active γ-IUD was the lowest (1.02/hundred women year) among three groups, and there were significant difference (P = 0.015). The rate of expulsion rate and discontinuation rate of active γ-IUD was 2.73/hundred women year, which was also the lowest among the three IUD, but there was no significantly statistical difference (P > 0.05).
CONCLUSIONS: The results showed that there are perfect clinical safety and effectiveness for three types of IUD immediately after vacuum aspiration. Active γ-IUD is superior to other two types IUD for its low medical removal rate which may be worthy to use widely immediately after vacuum aspiration.
METHODS: A multi-center randomized controlled clinical trial was performed in 12 medical institutions or family planning service stations located in China. Total 1800 eligible women were inserted G-Cu200, TCu380A or active γ-IUD randomly after vacuum aspiration immediately, and they were followed up for 12 months.
RESULTS: Except for 2 cases who dropped out (loss rate is 0.11%, 2/1800) and 17 cases who didn't match the including standard, the data of 1781 cases was analyzed. No any uterine perforation or ectopic IUD was found. During followed up 12 months, there was also no any pregnancy or pregnancy with IUD in situ occurred in the three groups. The medical removal rate for bleeding or (and) pain of active γ-IUD was the lowest (1.02/hundred women year) among three groups, and there were significant difference (P = 0.015). The rate of expulsion rate and discontinuation rate of active γ-IUD was 2.73/hundred women year, which was also the lowest among the three IUD, but there was no significantly statistical difference (P > 0.05).
CONCLUSIONS: The results showed that there are perfect clinical safety and effectiveness for three types of IUD immediately after vacuum aspiration. Active γ-IUD is superior to other two types IUD for its low medical removal rate which may be worthy to use widely immediately after vacuum aspiration.