Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Cardiac Output
研究概览
简要总结
A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.
详细描述
Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnant women for planned cesarean section
排除标准
- •Bleeding disorders
- •Placenta disorders
研究组 & 干预措施
carbetocin 100 µg
Carbetocin injection, 100µg, single injection
干预措施: carbetocin 100 µg (Drug)
oxytocin 5 u
Oxytocin 5U, injection, single injection
干预措施: oxytocin 5 u (Drug)
placebo (NaCl)
Saline single injection
干预措施: placebo (NaCl) (Drug)
结局指标
主要结局
Cardiac Output
时间窗: 2.5 minutes
The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.
Arterial Blood Pressure
时间窗: 2.5 min
The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.
次要结局
- Bleeding(120 minutes)
研究者
Leiv Arne Rosseland
Professor
Oslo University Hospital