NCT04089176已完成早期 1 期
Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnant Women With High Risk Postpartum Hemorrhage: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Additional drug use
研究概览
简要总结
Objective: study efficacy of carbtocin versus oxytocin for prevention postpartum hemorrhage in high risk pregnancy who undergo cesarean section
详细描述
Randomized controlled clinical trial. Defined patient in two group. Primary outcome is evaluate additional drug use Secondary outcome is evaluated estimated blood loss, hemoglobin level
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
- Double (Participant, Care Provider)
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
- •previous history of postpartum hemorrhage
- •polyhydramnios
- •fetal macrosomia
- •previous cesarean section
- •grand multiparity
- •intramural myoma
- •chorioamnionitis
- •prolonged premature rupture of membrane
- •augmentation of labour
排除标准
- •pregnancy induce hypertension
- •on anticoagulant
- •placenta previa or placenta percreta
研究组 & 干预措施
protocal A
Active Comparator
Carbetocin versus placebo
干预措施: Carbetocin (Drug)
protocal A
Active Comparator
Carbetocin versus placebo
干预措施: oxytocin (Drug)
protocal B
Active Comparator
Oxytocin versus placebo
干预措施: Carbetocin (Drug)
protocal B
Active Comparator
Oxytocin versus placebo
干预措施: oxytocin (Drug)
结局指标
主要结局
Additional drug use
时间窗: during intra-operation
Number of additional drug use after intervention drug
次要结局
- Side effect(During intra-opeartion and acute post operation period as 24 hours post operation)
- Estimate blood loss(During intra-opeartion and acute post operation period as 24 hours post operation)
- Hemoglobin level(Pre-operation and 24 hours post operation)
研究者
研究点 (1)
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