Administration of Oxytocin Via Intramuscular Injection and Intravenous Bolus or Intravenous Infusion in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,983
- 试验地点
- 2
- 主要终点
- Proportion of women with postpartum blood loss equal to or greater than 500 mL
研究概览
简要总结
The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage compared to intramuscular (IM) injection.
详细描述
The study will compare the effect of IV infusion or IV bolus to IM oxytocin administration with respect to mean blood loss and the proportion of women who experience blood loss greater than or equal to 500 ml, women who experience blood loss greater than or equal to 350 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women who present in active labor for a live birth at the study hospital will be considered for participation in the study
排除标准
- •Planned or transferred for delivery via Cesarean section
- •Administration of a pre-delivery uterotonic to induce or augment labor
- •Unable to provide informed consent due to mental impairment, distress during labor or other reason
研究组 & 干预措施
IV infusion
Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby.
干预措施: Oxytocin (Drug)
IV bolus
Oxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby.
干预措施: Oxytocin (Drug)
IM injection
Oxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Proportion of women with postpartum blood loss equal to or greater than 500 mL
时间窗: 1 hour after delivery of baby
Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.
次要结局
- Proportion of women with postpartum blood loss equal to or greater than 350 mL(1 hour after delivery of the baby)
- Time to delivery of placenta(Within 1 hour of delivery of the baby)
- Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy(Within 1 hour of delivery of the baby)
- Mean postpartum blood loss(1 hour after delivery of the baby)
- Proportion of women with postpartum blood loss equal to or greater than 1000 mL(1 hour after delivery)
- Side effects 1 hour postpartum(1 hour after delivery of the baby)
- Mean change in hemoglobin pre-delivery to postpartum(At least 12 hours after removal of IV and within 48 hours of delivery of the baby)