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首页> 外文期刊>BJOG: an international journal of obstetrics and gynaecology >Randomised controlled trial comparing efficacy of same day administration of mifepristone and misoprostol for termination of pregnancy with the standard 36- to 48-hour protocol.
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Randomised controlled trial comparing efficacy of same day administration of mifepristone and misoprostol for termination of pregnancy with the standard 36- to 48-hour protocol.

机译:随机对照试验比较了米非司酮和米索前列醇当日给药与标准36至48小时方案终止妊娠的疗效。

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摘要

Hypothesis That a 6-hour drug administration interval has similar efficacy and greater patient satisfaction as a 36- to 48-hour interval. Sample Four hundred and fifty patients. Methods A two-arm parallel design unblended randomised controlled trial in a single hospital. Eligible women up to 63 days of gestation will be invited to participate. Those willing will be randomised to either the experimental group (6 hours administration of misoprostol) or the control group (36-48 hours administration of misoprostol). All participants will take 200 mg mifepristone orally. At the time determined by study group allocation 800 mug misoprostol will be given intravaginally together with 100 mg diclofenac pr. Antibiotic prophylaxis as per the usual protocol will be given to each group. The control group will remain in hospital for 6 hours as per current policy and the study group will return home in 1 to 3 hours. Main outcome measure Complete medical abortion without need for further misoprostol or surgical evacuation. Secondary outcomes Duration of bleeding, side effects and acceptability based on questionnaire. Funding Source None.
机译:假设6个小时的给药间隔与36到48个小时的间隔具有相似的疗效和更高的患者满意度。样本450名患者。方法在一家医院进行两臂平行设计的无混合随机对照试验。长达63天的合格女性将被邀请参加。那些愿意的患者将被随机分为实验组(米索前列醇6小时)或对照组(米索前列醇36-48小时)。所有参与者将口服200毫克米非司酮。在研究组确定的时间点,将阴道内给予800杯米索前列醇与100 mg双氯芬酸pr。每组将按照常规方案进行抗生素预防。根据现行政策,对照组将在医院停留6个小时,研究组将在1-3个小时内返回家中。主要结果衡量指标完全的医学流产,无需进一步的米索前列醇或手术后撤离。次要结果根据问卷调查,出血持续时间,副作用和可接受性。资金来源无。

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