Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1,721
- 试验地点
- 1
- 主要终点
- Occurrence of post partum hemorrhage > 500mL in 1 hour
研究概览
简要总结
To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.
详细描述
Objective :
To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks'.
Method :
Double blinded Randomized controlled trial in two centers over 30 months.
Treatment :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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,
- •during first stage of normal labor,
- •at 36 to 42 weeks,
- •with epidural analgesia and informed signed consent
排除标准
- •Cesarean section delivery,
- •clotting disorders,
- •prostaglandin allergy,
- •absent consent.
研究组 & 干预措施
Misoprostol
10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp
干预措施: Misoprostol (Drug)
PLACEBO
10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Occurrence of post partum hemorrhage > 500mL in 1 hour
时间窗: 1 HOUR
次要结局
- Occurrence of post partum hemorrhage > 1000mL in 1 hour(1 HOUR)