Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Oxytocin dose
研究概览
简要总结
Introduction: postpartum hemorrage is a leading cause of death after cesarean sections in Brazil. Oxytocin is the main drug for both prophylaxis and threatment of postpartum hemorrage because uterine atony is the most prevalent cause. Both excessive and too low oxytocin doses threaten the life of women.
Objective: to determine the minimum effective dose of oxytocin for cesareans during labor.
Method: adaptative clinical trial using a modified up and down method of two sequential groups: rule of three and continuous infusion. Allocation in rule of three or continuous infusion will be random and masked for patients and anesthesiologists. The minimum effective dose will be the effective dose for 90% of success (ED90 for preventing uterine atony).
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cesarean delivery during labor.
- •Spinal anesthesia
排除标准
- •Change of anesthesia
研究组 & 干预措施
Rule of three
Intravenous bolus infusion of oxytocin 3UI followed by re-asessment of uterine tone by obstetrician after 3 minutes. Infusion stops when uterine tone is adequate and is repeated if inadequate to the maximum of 9UI (3 bolus infusions). If uretine tone is inadequate after 9UI then other methods for preventing bleeding will be used.
干预措施: Oxytocin (Drug)
Continuous infusion
Continuous infusion of variable rate if 0,4 UI of oxytocin until obstetrician determines that uterine tone is adequate.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Oxytocin dose
时间窗: 10 minutes
Minumum oxytocin dose for preventing uterine atony in 90% of cesareans.
次要结局
未报告次要终点
研究者
Gabriel Magalhaes Nunes Guimaraes
MD, MSc
Brasilia University Hospital