Intravenous and Intramuscular Administration of Oxytocin 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
- 653
- 试验地点
- 3
- 主要终点
- Mean blood loss (ml)
研究概览
简要总结
The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.
详细描述
The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 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
- •Women who are:
- •Planned or transferred for delivery via Cesarean section
- •Not delivering a live birth
- •Unable to provide informed consent due to mental impairment, distress during labor or other reason
- •Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.
研究组 & 干预措施
IV infusion
Oxytocin 10 IU will be administered IV infusion 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 IM 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
Mean blood loss (ml)
时间窗: minimum of 1 hour after delivery of baby
次要结局
- Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy(minimum of 1 hour after delivery of baby)
- Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml(minimum of 1 hour after delivery of baby)
- Time to placental delivery(minimum of 1 hour after delivery of baby)
- Side effects 1 hour postpartum(1 hour postpartum)
- Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward(arrival to labor ward)
- Change in hemoglobin from pre-delivery to postpartum(12-24 hours after delivery)