NCT00997347已完成4 期
The Extended Gestational Age Medical Abortion Study: The Effectiveness of Medical Abortion With Mifepristone and Misoprostol at 57-63 Days Versus 64-70 Days Gestation
Gynuity Health Projects12 个研究点 分布在 5 个国家目标入组 1,400 人开始时间: 2009年7月最近更新:
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
- 1,400
- 试验地点
- 12
- 主要终点
- Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion
研究概览
简要总结
This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •intrauterine pregnancy of greater than 56 days and less than 71 days
- •eligible for medical abortion according to study doctor assessment
- •willing and able to sign consent forms
- •speak English or Spanish (in US sites); speak the local language(s) (in international sites)
- •agree to comply with the study procedures and visit schedule
排除标准
- 未提供
研究组 & 干预措施
64-70 days' gestational age
Experimental
Women whose pregnancies are estimated to have a gestational age of 64-70 days
干预措施: Mifepristone and misoprostol (Drug)
结局指标
主要结局
Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion
时间窗: 7-36 days
次要结局
- Proportion of individual side effects experienced by participants(7-14 days)
- Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain)(7-14 days)
- Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began(7-14 days)
- Average number of missed days of work or school due to the abortion procedure(7-14 days)
研究者
研究点 (12)
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