Vaginal misoprostol for cervical priming before operative hysteroscopy: a randomized controlled trial.

Obstetrics & Gynecology(2018)

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摘要
To investigate the effectiveness of vaginal misoprostol for cervical priming before operative hysteroscopy and to assess the cervicouterine complications related to cervical dilatation and hysteroscopic surgery in nulliparous women.One hundred fifty-two women with definite intrauterine lesions were randomly assigned to receive either 200 microg vaginal misoprostol or placebo. Cervical response and outcome and complications of operative hysteroscopy were assessed.Thirty-five subjects were needed in each arm to detect a type I error of 0.01 with a power of 0.99. The mean cervical dilatation estimated by Hegar dilator was significantly different between the treated group (7.3 +/- 0.7 mm) and the control group (3.8 +/- 1.1 mm, P <.001). In the misoprostol group, 55 (75.3%) patients needed cervical dilation, compared with 75 (94.9%, P =.001) in the placebo group. The median time of cervical dilation to Hegar number 9 was significantly shorter in the treated group (40 seconds) compared with the control group (120 seconds, P <.001). The mean operative time was significantly shorter in the treated group (36.4 +/- 10.9 minutes) compared with the control group (45.9 +/- 14.2 minutes, P <.001). Cervical tears occurred in nine (11.4%) patients in the control group and in one (1.4%, P =.018) in the misoprostol group. Creation of a false tract was more common in the control group. Two uterine perforations occurred in the placebo group.Vaginal misoprostol applied before operative hysteroscopy reduced the need for cervical dilation, facilitated hysteroscopic surgery, and minimized cervical complications.
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关键词
randomized controlled trial,type i error,control group
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