A study to assess the role of rectal misoprostol when combined with standard oxytocin to prevent postpartum haemorrhage in vaginal delivery.

DrSMCSIMedical college1 个研究点分布在 1 个国家目标入组 320 人开始时间: 2014年1月1日最近更新: 2014年8月12日

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 320
试验地点: 1
主要终点: fall in haemoglobin and PCV levels

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized double blind placebo controlled trial to find the efficacy of 400mcg of rectal Misoprostol given after the delivery of the baby (in addition to standard dose of 10 units Oxytocin IM injection), in reducing postpartum haemorrhage in 320 patients undergoing vaginal delivery in Dr SM CSI Medical College Hospital for a period of one year. The primary outcome measures will be fall in haemoglobin and PCV levels after 24 hours of delivery. The secondary outcome will be duration of third stage of labour

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 21.00 Year(s) 至 35.00 Year(s)（—）
性别: Female

入选标准

•women with singleton pregnancy cephalic presentation >28 weeks of gestational age Hb>10gms.

排除标准

•patients undergoing cesarean section and instrumental delivery malpresentation multiple pregnancy past history of post partum haemorrhage coagulopathies heart disease/renal disease placenta previa/abruptio placenta.

结局指标

主要结局

fall in haemoglobin and PCV levels

时间窗: 24 hours

次要结局

Duration of third stage of labour

研究者

发起方

DrSMCSIMedical college

申办方类型

Private medical college

研究点 (1)

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