NCT01726478已完成不适用
Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.
Faculty of Medicine1 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2011年2月最近更新:
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
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Uterine tone adequacy
研究概览
简要总结
The purpose of the study was to determine whether 2.5 international units of oxytocin gives adequate uterine tone and is safe as compared to 10 international units of oxytocin following caesarean section delivery at Mulago hospital.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic disease)
- •Age between 18 to 40 years
- •Singleton pregnancies
排除标准
- •• Allergy to oxytocin
- •Ruptured uterus
- •Significant obstetric disease (including Pregnancy induced Hypertension, Eclampsia,)
- •Known risk factors for postpartum haemorrhage or uterine atony
- •Inherited or acquired coagulation disorder
- •History of post partum haemorrhage
研究组 & 干预措施
2.5 units oxytocin
Active Comparator
Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord
干预措施: 2.5 units Oxytocin (Drug)
10 units oxytocin
Placebo Comparator
Administration of 10 units of oxytocin after clamping of umbilical cord
干预措施: 10 units Oxytocin (Drug)
结局指标
主要结局
Uterine tone adequacy
时间窗: 2 minutes
The primary outcome was the assessment of either adequate or inadequate Uterine tone at various times after administration of initial oxytocin dose
次要结局
- Intraoperative blood loss(24 hours)
研究者
Faculty of Medicine
Dr Andrew Kintu
Makerere University
研究点 (1)
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