NCT00124540已完成不适用
Misoprostol for Preventing Postpartum Hemorrhage
Gynuity Health Projects5 个研究点 分布在 3 个国家目标入组 1,200 人开始时间: 2005年8月最近更新:
适应症
干预措施
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
- 1,200
- 试验地点
- 5
- 主要终点
- Blood loss =>500 mls within one hour after enrollment
研究概览
简要总结
This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.
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
- •Women who have given birth to 1 or more live-born infants (para 1 or more)
- •Vaginal delivery
排除标准
- •Refusal or inability to give informed consent
- •Delivery regarded as abortion according to local gestational age limits
- •Inability to take misoprostol sublingually
- •Cesarean section
- •Assisted vaginal delivery
研究组 & 干预措施
1
Placebo Comparator
placebo resembling misoprostol
干预措施: placebo (Drug)
2
Experimental
misoprostol
干预措施: misoprostol (Drug)
结局指标
主要结局
Blood loss =>500 mls within one hour after enrollment
次要结局
- Blood loss =>1000 mls within one hour after enrollment
- Mean blood loss after enrollment
- Blood transfusion
- Hemoglobin level <8 g/dL 24 hours after delivery
- Maternal morbidity and mortality
- Side effects
研究者
研究点 (5)
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