NCT05046041已完成4 期
A Study of Acceptability and Feasibility of an Outpatient "Day Procedure" for Medical Abortion at 13-18 Weeks Gestation in Two Public Sector Hospitals in Nepal
Gynuity Health Projects2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年11月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Proportion of participants with method success on the same day as misoprostol initiation.
研究概览
简要总结
This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation in two public sector facilities. It also seeks to document the roles of health workers in providing services related to later abortion care and to document the costs of this day procedure to the health system.
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
- •Have an ongoing pregnancy of 13-18 weeks gestation
- •Meet legal criteria to obtain abortion at 13-18 weeks gestation (Legal criteria include pregnancy resulting from rape or incest, fetal malformation and/or if the pregnancy affects the physical or mental health of the woman)
- •Have access to a phone where she can be reached at the 2-week follow up or willing to return to the clinic for an in-person interview with the research assistant
- •Be willing to follow study procedures
排除标准
- •Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- •Any contraindications to vaginal delivery
- •More than one prior cesarean delivery
- •Living more than 2 hours away from the hospital
研究组 & 干预措施
Mifepristone + Misoprostol
Experimental
200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3)
干预措施: Mifepristone + Misoprostol (Drug)
结局指标
主要结局
Proportion of participants with method success on the same day as misoprostol initiation.
时间窗: 0 - 48 hours after first dose of mifepristone
Success is defined as expelling fetus and placenta without surgical intervention and return home on the same day
次要结局
- Average pain scores(0 - 48 hours after first dose of misoprostol)
- Frequency of individual side effects experienced by participants(0 - 48 hours after first dose of misoprostol)
- Proportion of reported complications(0-2 weeks after initial visit)
- Average number of total doses of misoprostol(0 - 48 hours after first misoprostol dose)
- Average total hospital admission time(Within 0 - 48 hours after the second dose of misoprostol)
- Average induction-to-abortion interval(0 - 48 hours after first misoprostol dose)
- Description of tasks performed by different cadres of study staff(0 - 72 hours after receipt of mifepristone)
- Frequency of adverse events(0-2 weeks after initial visit)
- Proportion of satisfied participants(2 weeks after initial visit)
研究者
研究点 (2)
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