Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment
研究概览
简要总结
This is a pilot clinical trial to evaluate whether the medical management of early pregnancy failure with mifepristone and misoprostol is an effective and acceptable treatment. Subjects with early pregnancy failure receive mifepristone followed 24 hours later by vaginal misoprostol for medical management. Subjects then return on study day 3 for a repeat ultrasound to assess passage of pregnancy tissue. subjects who still have a gestational sac present at Day 3 receive a second dose of vaginal misoprostol. All subjects have a follow-up at Day 15, by phone for those who passed the pregnancy with the first dose of misoprostol, and in person for those who received a second dose. Questionnaires are administered at the beginning and end of the study to determine acceptability.
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
- •healthy hemodynamically stable females with a non-viable pregnancy
排除标准
- •orthostatic hypotension, contraindication to either mifepristone or misoprostol, treatment during current pregnancy to provide surgical or medical evacuation of the uterus, evidence of ovarian hyperstimulation syndrome, known or suspected pelvic infection,known or suspected clotting defect or receiving anticoagulants, cardiovascular disease, current breastfeeding, pregnancy with and IUD in situ, current participation in another clinical trial, prior participation in this trial, suspected or confirmed endometrial AV malformation, clinical indication requiring the karyotyping of products of conception
研究组 & 干预措施
1
Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
干预措施: mifepristone/misoprostol (Drug)
结局指标
主要结局
to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment
时间窗: 1-2 weeks
次要结局
- to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medications(1-2 weeks)
- to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure(1-2 weeks)
- to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure(1-2 weeks)