Chart Review Study of Medical Abortion at 64-70 Days of Gestation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 579
- 试验地点
- 2
- 主要终点
- Abortion Success
研究概览
简要总结
The primary objective of this study is to document the rates of success and serious complications among women having outpatient medical abortions with 200 mg mifepristone + 800 buccal misoprostol at 64-70 days of gestation.
详细描述
The study will be conducted at US abortion clinics that have offered medical abortion with 200 mg mifepristone + 800 mcg buccal misoprostol to at least 20 women at 64-70 days of gestation. Designated staff at each site will review clinic records to identify and record data from every patient treated in that gestational week. Once data collection is completed, if the rate of success or serious complications at any clinic is substantially discordant from rates documented in the published literature, we may collect additional data on patients seeking medical abortion at 57-63 days, to aid in explaining results found in the 64-70 days group. In this situation, for each patient in the 64-70 days group, site staff will identify and record data from the next consecutive patient treated with this regimen at 57-63 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women at 64-70 days of gestation
- •Received 200 mg mifepristone + 800 mcg buccal misoprostol for a medical abortion
排除标准
- •Does not meet the inclusion criteria
结局指标
主要结局
Abortion Success
时间窗: 1 week
Defined as a complete abortion without use of surgery
Serious complications
时间窗: 1 month
Defined as admission to hospital, receipt of parenteral antibiotics, surgery (laparoscopies, laparotomies, hysterectomies), transfusion, or death
次要结局
- Proportion of complete abortions without additional treatment(1 week)
- Proportion of ongoing pregnancies(1 week)
- Proportion of significant abortion complications(1 month)