NCT01931410已完成4 期
The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial
Istanbul Bakirkoy Maternity and Children Diseases Hospital0 个研究点目标入组 618 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 618
- 主要终点
- Postpartum Haemorrhage
研究概览
简要总结
The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •live and singleton pregnancy
- •Elective caesarean
- •Gestational week greater than 37 weeks
- •patient between 18-44 year old
排除标准
- •multiple pregnancy
- •Preeclampsia
- •Gestational diabetes
- •Oligohidraamnıos
- •Polihidraamnıos
- •Morbid obesity
- •Coagulatıon defect (such as HELLP syndrome)
研究组 & 干预措施
sublingual
Placebo Comparator
400 microgram mısoprostol will be administered sublıngually before elective caesarean
干预措施: Misoprostol (Drug)
rectal
Placebo Comparator
rectal 600 mgr misoprostol will be administered
干预措施: Misoprostol (Drug)
结局指标
主要结局
Postpartum Haemorrhage
时间窗: postpartum 24 hour
次要结局
未报告次要终点
研究者
Osman Aşıcıoğlu
M.D. Obstetric and Gynecology
Istanbul Bakirkoy Maternity and Children Diseases Hospital
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