NCT02046499已完成不适用
A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section
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
- Triple (Participant, Care Provider, Investigator)
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
- •Pregnant women delivering by caesarean section older than 18 years willing and able to give informed consent
排除标准
- •• Women not willing or women not able to provide consent
- •Women who have a classical caesarean section
- •Women younger than 18 years of age
- •Women with any of the following conditions will be excluded (ergometrine contra-indicated in patients with these conditions).
- •Pre- eclampsia
- •Eclampsia,
- •Uncontrolled hypertension (hypertension defined as systolic blood pressure more than 140 mm Hg and diastolic blood pressure more than 90 mm Hg)
- •Any cardiac lesion
- •Impaired liver function
- •Impaired kidney function
- •Hypersensitivity to any of the active ingredients of the preparations that will be used (Syntometrine® or Syntocinon®)
- •Occlusive vascular disease
- •Autoimmune vasculitis
研究组 & 干预措施
Oxytocin arm
Active Comparator
Oxytocin alone administered which is current standard of care
干预措施: Oxytocin (Drug)
Oxytocin + syntometrine
Experimental
Oxytocin plus syntometrine administered
干预措施: Oxytocin ergometrine (Drug)
结局指标
主要结局
Blood loss
时间窗: 60 minutes
Estimated blood loss at caesarean section
次要结局
- Side effects of oxytocin compared to oxytocin + ergometrine(24 hours)
- Need for additional uterotonics(60 minutes)
- Number of units blood transfused(24 hours)
研究者
Leon Snyman
Principal Specialist
University of Pretoria
研究点 (1)
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