NCT02048098已完成3 期
A Comparison Between Vaginal Misoprostol vs. Buccal Misoprostol For Second Trimester Termination of Pregnancy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Induction to fetal expulsion interval
研究概览
简要总结
The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3 hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable pregnancy
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
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •gestational age between 12-24 weeks
- •live fetus
- •singleton pregnancy
- •Bishop score <5
- •no uterine contraction
排除标准
- •prostaglandin allergy
- •a scar in uterus
- •uterine abnormality
- •premature rupture of membranes
研究组 & 干预措施
Buccal misoprostol
Active Comparator
400 µg buccal misoprostol per 3 hours
干预措施: Buccal misoprostol (Drug)
vaginal misoprostol
Active Comparator
400 µg vaginal misoprostol per 3 hours
干预措施: Vaginal misoprostol (Drug)
结局指标
主要结局
Induction to fetal expulsion interval
时间窗: 15 minutes after fetus delivered
Time elapsed between administration of the first misoprostol dose until expulsion of the fetus
次要结局
- Delivery within 24 hours(24 hour)
- Delivery within 48 hours(48 hours)
- Rate of complete abortion(12 hour after fetus and placenta removed)
- Expected pain before induction and perceived (actual) pain after abortion completed(within 1 hour after randomisation and after 12 hour after complete abortion/placenta removed)
- Use of additional interventions(One week)
研究者
Ragıp Atakan Al
Associate Professor
Ataturk University
研究点 (1)
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