Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- prevention of post partum hemorrhage after CS
研究概览
简要总结
to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section
详细描述
A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.
Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All participants are at 37 - 40 weeks of gestational age
- •Noncomplicated pregnancy.
排除标准
- •Participants with placenta previa
- •Patients with coagulopathy
- •preeclamptic women
- •known sensitivity to oxytocin or methergine were excluded
研究组 & 干预措施
carbetocin
single 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal.
干预措施: carbetocin (Drug)
Syntometrine
Intravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.
干预措施: Syntometrine (Drug)
结局指标
主要结局
prevention of post partum hemorrhage after CS
时间窗: 24 hours
Number of participants experienced postpartum hemorrhage
次要结局
- side effects of drugs used(24 hours)
研究者
Ahmed M Maged, MD
Assistant professor
Cairo University