NCT01173003已完成不适用
An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP
Gynuity Health Projects1 个研究点 分布在 1 个国家目标入组 688 人开始时间: 2009年6月1日最近更新:
适应症
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
- 688
- 试验地点
- 1
- 主要终点
- Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
研究概览
简要总结
This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.
The goal of this study is to provide answers to the following four questions:
- What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)?
- Are the side effects with sublingual use tolerable for women?
- Is sublingual administration of misoprostol acceptable to women?
- Are women satisfied with counseling and services received in new centers offering medical abortion?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women presenting for medical abortion who consent to participate
- •Possibility of final gestational age of less than or equal to 63 days
- •General good health
- •Willing to provide contact information for purposes of follow-up
排除标准
- •Conditions which contraindicate the use of mifepristone or misoprostol
- •Women presenting for medical abortion who do not consent to participate
结局指标
主要结局
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
时间窗: 2 weeks after mifepristone administration
次要结局
- Side effects(48 hours)
- Acceptability for women(2 weeks)
研究者
研究点 (1)
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