Second-line Treatment of Post-partum Haemorrhage With Intrarectal Misoprostol: a Multicentre, Double Blind, Randomized Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 主要终点
- quantification of blood loss
研究概览
简要总结
Postpartum haemorrhage (PPH) remains the major cause of maternal mortality in France. The most efficient treatment of severe PPH is sulprostone which is associated with cardiac complications. The objective of this study was to assess the efficacy and the safety of intrarectal misoprostol for curative postpartum haemorrhage treatment.
We conducted a multicenter double blind randomized placebo control trial between June 2004 and December 2007, among consenting women with postpartum haemorrhage and failure to oxytocin treatment.
Our main criteria of judgement was quantification of blood loss and the use of sulprostone between the two groups using either misoprostol intrarectal tablets (5X200mg ) or placebo in similar opaque introducer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Older than 18 yrs old
- •Giving birth after 32 Weeks of amenorrhea
- •Post-partum haemorrhage due to atony
- •Inefficiency off the first line treatment
- •Written signed consent form
排除标准
- •known allergy to prostaglandin
- •haemostasis anomalies before labour
- •anticoagulant treatment
- •fetal death
- •accreta or percreta placenta
- •under 18 years
- •delivery before 32 weeks of amenorrhea
- •post-partum bleeding not suspected to be due to atonic uterus
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
MISOPROSTOL
干预措施: Misoprostol (Drug)
结局指标
主要结局
quantification of blood loss
时间窗: 15 minutes after treatment administration
quantification of blood loss and the use of sulprostone between the two groups using either misoprostol intrarectal tablets (5X200mg ) or placebo in similar opaque introducer
次要结局
- Sulprostone Requirement(30 minutes after the diagnostic of post-partum hemorrhage)