NCT02707653已完成不适用
Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research
Gynuity Health Projects2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Percentage of women with complete uterine evacuation with study medication alone.
研究概览
简要总结
This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.
详细描述
This open-label feasibility study seeks to examine the potential of 400μg sublingual misoprostol for the treatment of incomplete abortion provided at tertiary hospitals.
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
- 年龄范围
- 12 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Confirmed incomplete abortion
- •No known contraindications to the study drug
- •Uterine size no larger than 12 weeks at time of presentation for care
- •No signs of severe infection, defined as at least two of the following:
- •foul smelling discharge,
- •fever > 38 degrees C, 100 degrees Fahrenheit
- •uterine tenderness.
- •No hemodynamic disturbances (pulse >110/min and systolic bp <100)
- •General good health
- •Agree to comply with study procedures including return for follow up visit
- •Live or work within one hour from a study site
- •Willing and able to sign consent forms
排除标准
- •Inability to provide informed consent
研究组 & 干预措施
Miso
Other
Misoprostol 400 s/l
干预措施: Misoprostol (Drug)
结局指标
主要结局
Percentage of women with complete uterine evacuation with study medication alone.
时间窗: 14 days
次要结局
- Level of self-reported acceptability of treatment(7-14 days)
- Percentage of women experiencing side effects(7-14 days)
研究者
研究点 (2)
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