Zhonghua fu chan ke za zhi · 2009
[Efficacy of intrauterine device TCu380A when inserted in four different periods].
Клиническое исследованиеСравнительное исследованиеАннотация на английскомСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Wu Shang-Chun, Research Group on Failure Causes and Prevention Measures of Intrauterine Device
Аннотация
OBJECTIVE: To compare the effectiveness of TCu380A intrauterine device (IUD) inserted in menstrual interval, immediately after vacuum aspiration, and early and later lactation periods.
METHODS: A comparative, multicentre clinical trial was performed. Totally 2293 eligible women were inserted TCu380A IUD during the above mentioned 4 different period.
RESULTS: Among 2293 women, 852 cases inserted in menstrual interval, 591 cases of them immediately inserted after vacuum aspiration, and 451 cases and 399 cases of them inserted at early and later lactation periods. By the end of 1st year, no uterine perforation and pelvic inflammatory disease were found. The pregnancy rates with IUD in situ from the four groups were low (< or = 0.51/hundred women year). The rate of removal for displacement in the group of later lactation period was the highest (8.08/hundred women year), while the lowest (3.97/hundred women year) in the group of immediately after vacuum aspiration. There were significant difference among the four groups (P < 0.05). The lowest rates of the total or partial expulsion were in the later lactation group, which were 0.25 and 0.26/hundred women year. The medical removal rate for bleeding and (or) pain in the four groups were 1.94, 1.73, 1.42 and 1.33/hundred women year, and there were no significantly difference among the four groups (P > 0.05).
CONCLUSION: Insertion of TCu380A IUD in the above mentioned four periods are feasible, safe and effectiveness.
METHODS: A comparative, multicentre clinical trial was performed. Totally 2293 eligible women were inserted TCu380A IUD during the above mentioned 4 different period.
RESULTS: Among 2293 women, 852 cases inserted in menstrual interval, 591 cases of them immediately inserted after vacuum aspiration, and 451 cases and 399 cases of them inserted at early and later lactation periods. By the end of 1st year, no uterine perforation and pelvic inflammatory disease were found. The pregnancy rates with IUD in situ from the four groups were low (< or = 0.51/hundred women year). The rate of removal for displacement in the group of later lactation period was the highest (8.08/hundred women year), while the lowest (3.97/hundred women year) in the group of immediately after vacuum aspiration. There were significant difference among the four groups (P < 0.05). The lowest rates of the total or partial expulsion were in the later lactation group, which were 0.25 and 0.26/hundred women year. The medical removal rate for bleeding and (or) pain in the four groups were 1.94, 1.73, 1.42 and 1.33/hundred women year, and there were no significantly difference among the four groups (P > 0.05).
CONCLUSION: Insertion of TCu380A IUD in the above mentioned four periods are feasible, safe and effectiveness.