A Randomized Comparison of Same-Day Oral Mifepristone-Misoprostol to Misoprostol Only for Cervical Preparation in Second Trimester Surgical Abortion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Initial Cervical Dilation
研究概览
简要总结
A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.
详细描述
Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6 hours prior to D&E. Primary outcome was cervical dilation assessed by the largest Hegar dilator accepted without resistance. Secondary outcomes included total procedure time, and patient and provider perceptions. The study was powered to detect a 2-mm difference in cervical dilatation with 48 participants in each arm.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women
- •eligible for non---urgent D&E
- •14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram
排除标准
- •emergent need for D&E
- •fetal demise
- •intolerance
- •allergy or contraindication to mifepristone or misoprostol
研究组 & 干预措施
Mifepristone
Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once
干预措施: Mifepristone (Drug)
Mifepristone
Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once
干预措施: Misoprostol (Drug)
Placebo
Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once
干预措施: Misoprostol (Drug)
Placebo
Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Initial Cervical Dilation
时间窗: Assessed 4-6 hour following medications at time of D&E procedure
Initial cervical dilation as measured by Hegar Dilator accepted with least resistance
次要结局
- Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)(intraoperative)