Acceptability and Feasibility of Medical Abortion in Mexico, Puerto Rico, Armenia and Azerbaijan: A Study of Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days' Gestation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,250
- 试验地点
- 11
- 主要终点
- efficacy
研究概览
简要总结
This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen would be both acceptable and efficacious.
详细描述
The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone, followed by 800 buccal misoprostol. They later underwent clinic follow-up to determine if their medical abortions were complete. The study assessed the acceptability and feasibility of the above regimen and sought to determine the efficacy and acceptability of buccal administration of misoprostol as well as the acceptability of side effects experienced by women.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestation up to 63 days
- •General good health
- •Willingness to provide contact information for follow-up
- •Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination
排除标准
- •Ectopic pregnancy
- •Intrauterine device (IUD) in place
研究组 & 干预措施
mifepristone-misoprostol treatment
200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone
干预措施: mifepristone-misoprostol treatment (Drug)
结局指标
主要结局
efficacy
时间窗: 15 days
次要结局
- acceptability(15 days)