NCT00945997已完成不适用
Mifepristone (RU 486) and Misoprostol for Second Trimester Termination of Pregnancy. A Comparison of Two Different Dose Regimens.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2000年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Expulsion rate and the number of incomplete abortions warranting surgical evacuation of retained products of conception.
研究概览
简要总结
To compare the efficacy of two different dose regimens of misoprostol administered vaginally in combination with mifepristone in second trimester termination of (non)viable pregnancy.
详细描述
The study was designed as a prospective double blinded randomised controlled trial, comparing 200µg to 400 µg misoprostol given vaginally at four hour intervals, starting 36-48 hours after the oral administration of mifepristone 200 mg at a gestational age between 14 to 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a gestational age between 14 to 24 weeks, confirmed by ultrasound, requesting termination of pregnancy
排除标准
- •No informed consent
- •Mifepristone allergy
- •Chronic adrenal gland failure
- •Kidney failure
- •Liver failure
- •Chronic use of corticosteroids
- •COPD not responsive to treatment
- •Cardiovascular disease
研究组 & 干预措施
A
Active Comparator
干预措施: misoprostol (Drug)
B
Active Comparator
干预措施: misoprostol (Drug)
结局指标
主要结局
Expulsion rate and the number of incomplete abortions warranting surgical evacuation of retained products of conception.
时间窗: 8 weeks
次要结局
- time between the first administration of misoprostol to to delivery of the foetus(48 hours)
研究者
研究点 (1)
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