Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage in Obese Women Undergoing Elective Cesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- incidence of postpartum 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 1200 obese pregnant subjected randomly either to single 100 μg IV dose of carbetocin (600 women) or combination of 5 IU oxytocin and 0.5 mg ergometrine (600 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
- 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.
- •obese women with BMI > 30.
排除标准
- •Participants with placenta previa,
- •coagulopathy,
- •preeclamptic
- •known sensitivity to carbetocin,oxytocin or methergine were excluded
研究组 & 干预措施
carbetocin
600 women received single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
干预措施: carbetocin (Drug)
Syntometrine
600 women received one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 micrograms of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes
干预措施: Syntometrine (Drug)
结局指标
主要结局
incidence of postpartum hemorrhage after CS
时间窗: 24 hours
Number of participants experienced massive postpartum hemorrhage
次要结局
- side effects of drugs used(24 hours)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University