NCT03651882已完成4 期
Intramyometrial and Intravenous Oxytocin Compared to Intravenous Carbetocin for Prevention of Postpartum Hemorrhage in Elective Cesarean Sections - a Monocentric Randomized Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- incidence of women with a delta hemoglobin ≥ 30g/l.
研究概览
简要总结
Objective is to proof non-inferiority of intramyometrial and intravenous oxytocin application compared to intravenous carbetocin for prevention of postpartum hemorrhage in planned, uncomplicated cesarean deliveries.
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
- None
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
- •elective cesarean section
- •present informed consent
- •completed 36 weeks of gestation
排除标准
- •need for intubation (carbetocin is only licensed for epidural or spinal anesthesia)
- •multiple fetus pregnancy
- •known coagulopathy
- •Placenta praevia
- •morbidly adherent placenta
- •placental abruption
- •thrombocyte dysfunction
- •HELLP-syndrome
- •preeclampsia
- •history of uterine atony
研究组 & 干预措施
Oxytocin
Active Comparator
干预措施: Oxytocin (Drug)
Carbetocin
Active Comparator
干预措施: Carbetocin (Drug)
结局指标
主要结局
incidence of women with a delta hemoglobin ≥ 30g/l.
时间窗: 48 hours
Delta hemoglobin is defined as the difference of the hemoglobin at admission minus the hemoglobin after delivery, usually 24-48 hours after the delivery.
次要结局
- adverse maternal outcome parameters(15 days)
研究者
研究点 (1)
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