NCT02235155已完成不适用
Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Uzbekistan
Gynuity Health Projects3 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2014年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 3
- 主要终点
- Proportion of abortions that are complete as a measure of efficacy
研究概览
简要总结
The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Meet legal criteria to obtain abortion
- •Have an ongoing pregnancy of 13-22 weeks gestation
- •Be willing to undergo a surgical completion if necessary
- •Have no contraindications to study procedures, according to provider
- •Be willing and able to consent to procedure, either by reading consent document or by having consent document read to her
- •Be willing to follow study procedures
排除标准
- •Known previous transmural uterine incision
- •Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- •Any contraindications to vaginal delivery, including placenta previa
结局指标
主要结局
Proportion of abortions that are complete as a measure of efficacy
时间窗: At 15 hours after the start of misoprostol administration
It is a proportion that specifies how many abortions out of all initiated abortions are complete without recourse to surgical intervention within 15 hours after the start of misoprostol administration.
次要结局
- Interval of time between induction with misoprostol to complete abortion(Every 3 hours from the start of misoprostol administration until complete abortion)
- Pain experienced by women(At the time of discharge, up to 5 days after enrollment)
- Women's satisfaction with the method(At discharge, up to 5 days after enrollment)
- Side effects experienced by women(Every 3 hours from the start of misoprostol administration until complete abortion)
- Provider's perception of acceptability of the method(At study completion, up to 2 years after study enrollment commences)
- Complications during induction and after discharge(Every 3 hours from the start of misoprostol administration, up to 1 month after discharge)
- Women's perception of acceptability of the procedure(At discharge, up to 5 days after enrollment)
- Total dose of misoprostol administered(Every 3 hours from start of misoprostol administration to complete abortion)
研究者
研究点 (3)
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