Assessing the Effectiveness, Safety and Feasibility of Expanding Use of Oxytocin in Uniject™ by Auxiliary Nurse Midwives to Prevent Postpartum Hemorrhage: A Community-based Cluster Randomized Trial in Bagalkot, India
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- postpartum hemorrhage
研究概览
简要总结
This cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from 9% to 5%) relative to home births attended by the same type of provider who does not provide the intervention drug. The study will also document correct use of oxytocin in Uniject, adverse maternal and fetal events associated with inappropriate use and a number of indicators reflecting the programmatic feasibility of implementing this intervention.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •gestational age >=28 wks at enrollment
- •anticipate spontaneous vaginal delivery
- •hemoglobin >=8 gm/dl
- •delivery at home, sub-center, or primary health center
- •delivery attended by Auxilliary Nurse Midwife
排除标准
- •previous caesarean-section
- •scheduled for caesarean-section
- •antepartum bleeding during current pregnancy
- •blood pressure >140mm of Hg systolic and >90mm of Hg diastolic
- •in active labor at time of recruitment
- •high risk medical conditions (diabetes, cardiac ailments, seizures, placenta previa, anticipated breech delivery
结局指标
主要结局
postpartum hemorrhage
时间窗: after delivery of baby
blood loss \>=500 ml after delivery of the baby, as measured through a plastic calibrated drape.
次要结局
- Oxytocin use before delivery(labor and delivery)
- stillbirth(pregnancy)
- neonatal death(first month of life)
- need for neonatal resuscitation(0-6 hours after birth)