NCT01539408已完成1 期
Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Gynuity Health Projects2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Complete abortion without recourse to surgical intervention
研究概览
简要总结
Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •no contraindications to misoprostol
- •uterine size was not larger than 12 weeks
- •there were no signs of severe infection
- •haemodynamically stable
- •in general good health
- •willing to provide contact information
排除标准
- •an IUD in place
- •ectopic pregnancy
- •aged below 18 years and had no accompanying adult to provide informed consent
研究组 & 干预措施
Misoprostol
Active Comparator
400 mcg of sublingual misoprostol in one dose
干预措施: Misoprostol (Drug)
Manual vacuum aspiration (MVA)
Active Comparator
Standard surgical treatment (MVA)
干预措施: surgery Manual vacuum aspiration (MVA) (Procedure)
结局指标
主要结局
Complete abortion without recourse to surgical intervention
时间窗: follow up visit 7 days after initial treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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