Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage: A Randomized Cluster Non-Inferiority Study in El Beheira Governorate, Egypt
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,827
- 试验地点
- 1
- 主要终点
- Mean drop in pre- to post-delivery hemoglobin level
研究概览
简要总结
The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of PPH care using misoprostol.1. The study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.
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
- •Willing and able to give informed consent
- •Vaginal delivery
- •Agrees to participate in follow-up interview
- •Agrees to have pre- and post-hemoglobin taken
- •Delivery at woman's home or at the primary health unit (PHU)
排除标准
- •Too advanced into active labor to provide consent
- •Known allergy to misoprostol and/or other prostaglandin
- •Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, ante-partum hemorrhage, and previous complication in the third trimester
研究组 & 干预措施
Secondary prevention
Single sublingual dose of 800mcg (4 tablets) misoprostol administered to women with 350-500mL postpartum blood loss as estimated using a blood absorption mat or due to deteriorating postpartum condition of the woman as determined by provider's clinical judgment
干预措施: Misoprostol (Drug)
Universal prophylaxis
Single oral prophylactic dose of 600mcg (3 tablets) misoprostol administered to all women within 1 minute of deliver of baby
干预措施: Misoprostol (Drug)
结局指标
主要结局
Mean drop in pre- to post-delivery hemoglobin level
时间窗: Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.
Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.
次要结局
- Proportion of women diagnosed with PPH(After delivery of the baby up to 24 hours postpartum)
- Proportion of women who receive intervention per protocol(within 2 hours of delivery)
- Proportion of women who experience side effects(From time of delivery to 2 hours postpartum)
- Proportion of women transferred to higher level care(Following delivery to postpartum visit (2 to 4 days after delivery))
- Proportion of women receiving additional interventions for PPH(Following delivery to postpartum visit (2 to 4 days after delivery))
- Proportion of women who find the intervention acceptable(Measured at postpartum visit (2 to 4 days after delivery))
- Proportion of women experiencing a serious adverse event(Within 2 to 4 days after delivery)