NCT00120237已完成不适用
A Placebo-Controlled Randomized Trial of Misoprostol in the Management of the Third Stage of Labor in the Home Delivery Setting in Rural Pakistan
Gynuity Health Projects1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2005年7月1日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Postpartum hemorrhage (blood loss >or= 500 mL)
研究概览
简要总结
This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women in general good health, home delivery
- •Must live in one of 78 study villages
排除标准
- •Hypertension
- •Non-cephalic presentation
- •Polyhydramnios
- •Previous cesarean section
- •Suspected multiple pregnancy
- •Suspected still birth
- •Antepartum hemorrhage
- •Previous complication in 3rd trimester
- •Anemia of <8 g/dl
结局指标
主要结局
Postpartum hemorrhage (blood loss >or= 500 mL)
时间窗: Measured at 1 hour postpartum or until active bleeding has stopped
Drop in hemoglobin > 2 g/dL from pre to post-delivery
时间窗: Hemoblobin (Hb) level measured 3-5 days after delivery
次要结局
- Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL)(Blood loss measured at 1 hr postpartum or until active bleeding stopped)
- Mean blood loss(blood loss measured at 1 hr postpartum or until active bleeding stopped)
- Side effects experienced among recently delivered mothers(Interviews conducted 1 day post-delivery)
- Anemia (<9 g/dL and <11 g/dL)(Postpartum hemoglobin assessed 3 days post-delivery)
研究者
研究点 (1)
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