NCT02314754已完成4 期
Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation: A Non-inferiority Trial
Gynuity Health Projects8 个研究点 分布在 5 个国家目标入组 719 人开始时间: 2014年12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
- 719
- 试验地点
- 8
- 主要终点
- Efficacy as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason
研究概览
简要总结
To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.
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
- 11 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •intrauterine pregnancy between 64 days and 77 days' LMP
- •eligible for medical abortion according to study doctor assessment
- •willing and able to sign consent form
- •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
- •Have known allergies or present other contraindications to mifepristone or misoprostol
研究组 & 干预措施
71-77 days gestational age
Experimental
Women whose pregnancies are estimated to have a gestational age of 71-77 days.
干预措施: Mifepristone followed by misoprostol 24-48 hours later (Drug)
结局指标
主要结局
Efficacy as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason
时间窗: 7-36 days
Efficacy of medical abortion in the later first trimester as determined by the proportion of successful terminations without surgical intervention (suction curettage or D\&C) for any reason
次要结局
- Proportion of Providers Who Determine Method Acceptable(7-36 days)
- Proportion of Women Who Determine Method Acceptable(7-14 days)
- Proportion of Individual Side Effects Experienced by Participants(7-14 days)
研究者
研究点 (8)
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