Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg 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
- 1,220
- 试验地点
- 4
- 主要终点
- Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22).
研究概览
简要总结
This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.
详细描述
The goal of this study is to provide answers to the following four questions:
- Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?
- Are the side effects with buccal use tolerable for women?
- Is buccal administration of misoprostol acceptable to women?
- When given a choice, do women prefer to take misoprostol at home or in the clinic?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Women 18 years or over presenting for abortion services who consent to participate
- •good general health
- •assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion
- •Have ready access to a telephone and emergency transportation;
- •Be willing to provide an address and/or telephone number 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
研究组 & 干预措施
1
200mg mifepristone followed by 400mcg misoprostol
干预措施: mifepristone, misoprostol (Drug)
2
200mg mifepristone followed by 800mcg misoprostol
干预措施: mifepristone, misoprostol (Drug)
结局指标
主要结局
Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22).
时间窗: Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit
次要结局
- Side-effects, acceptability for women(side effects and acceptability recorded at exit interview)