Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Complete pregnancy evacuation on ultrasound at 3 weeks
研究概览
简要总结
In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol. This is recommended orally at a dose of 400 μg. There are currently several studies on the subject, including a meta-analysis of the 2011 Cochrane Database, but doses, routes of administration and gestational age differ in all studies. Currently, HAS recommends the vaginal route at the dose of 800μg for stopped pregnancies. It is therefore necessary to compare the different routes of administration of Misoprostol at the same dose to allow to change our French recommendations on the medicinal abortion and perhaps also to recommend the vaginal route in this indication.
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
- 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
- 否
入选标准
- •Women > 18 years hospitalized using abortions between 7 and 9 SA and after informed consent,
- •Affiliation to a social security scheme.
排除标准
- •Minor or major women under guardianship or curatorship
- •BMI <18.5 (thinness)
- •Ambulatory
- •Several abortions on the duration of the study
- •Take Mifepristone> 48 hours before taking Misoprostol
- •Contraindications to Misoprostol: Prostaglandin Allergy
研究组 & 干预措施
Administration of oral Misoprostol
干预措施: Assess the efficacy and side effects of Misoprostol according to the route of administration (Biological)
Administration of Misoprostol vaginally
干预措施: Assess the efficacy and side effects of Misoprostol according to the route of administration (Biological)
Administration of buccal Misoprostol
干预措施: Assess the efficacy and side effects of Misoprostol according to the route of administration (Biological)
结局指标
主要结局
Complete pregnancy evacuation on ultrasound at 3 weeks
时间窗: 3 weeks
次要结局
未报告次要终点