NCT03269279Unknown3 期
Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso
Gynuity Health Projects4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年5月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Rate of successful abortion
研究概览
简要总结
The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Burkina Faso.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having an ongoing pregnancy of 13-22 weeks gestation
- •Be willing to undergo surgical completion if necessary
- •Have no contraindications to study procedures, according to provider
- •Be willing and able to consent to participate in the study
- •Be willing to follow study procedures
- •Respect legal indications for obtaining an abortion
排除标准
- •Known allergy to mifepristone or misoprostol/prostaglandin
- •Any contraindications to vaginal delivery, including placenta previa
- •Previous transmural uterine incsion
研究组 & 干预措施
Medical abortion arm
Experimental
200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester
干预措施: Mifepristone (Drug)
Medical abortion arm
Experimental
200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester
干预措施: Misoprostol (Drug)
结局指标
主要结局
Rate of successful abortion
时间窗: 24 hours
Rate of successful abortion, complete evacuation of foetus and placenta with study drugs, within 24 hours of taking misoprostol
次要结局
未报告次要终点
研究者
研究点 (4)
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