The Oxytocin Initiative: Determining the Effect of Prophylactic Administration of Oxytocin in Uniject™ by a Community Health Officer on Postpartum Hemorrhage at Home Births in Four Districts in Ghana
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,586
- 试验地点
- 1
- 主要终点
- postpartum hemorrhage-1
研究概览
简要总结
This study is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO) at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative to home births attended by the same type of provider who does not provide a uterotonic drug.
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •home delivery
- •presence of Community Health Officer at time of delivery
排除标准
- 未提供
研究组 & 干预措施
Oxytocin in Uniject
Community Health Officers will provide 10 IU Oxytocin in Uniject device IM immediately after delivery of baby
干预措施: Oxytocin in Uniject (Other)
PPH Treatment Only
Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject
结局指标
主要结局
postpartum hemorrhage-1
时间窗: after delivery of baby
blood loss \>=500 ml after delivery of the baby, as measured through plastic calibrated drape
postpartum hemorrhage-2
时间窗: after delivery of the baby
blood loss \>=500ml OR treatment dose of oxytocin provided
postpartum hemorrhage-3
时间窗: after delivery of the baby
blood loss \>=500ml OR treatment dose of oxytocin provided OR referral for bleeding
次要结局
- Oxytocin use before delivery(labor and delivery)
- stillbirth(labor/delivery)
- neonatal death(first month of life)
- need for neonatal resuscitation(0-6 hours after birth)