CTRI/2009/091/000075已完成不适用
A randomised double- blind well controlled clinical trial to compare the efficacy and safety of rectally administered Misoprostol and Intravenous Oxytocin infusion in preventing intraoperative and postpartum blood loss in women undergoing caesarean section.
Chittaranjan Sevasadan HospitalSPMukherjee Road Kolkata1 个研究点 分布在 1 个国家目标入组 0 人开始时间: 2007年1月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- blood loss during operation and 8 hours postpartum and change in the hemoglobin 24 hours after delivery.
研究概览
简要总结
This is a randomised ,double -blind, parallel group trial comparing the widely used intravenous Oxytocin infusion and rectally adminstered Misoprostol in low risk women undergoing caesarean section with a primary outcome measure of assessing the intraoperative and postpartum blood loss over next 8 hours and change in Hb%.Secondary outcome measures ,additional oxytocic requirement,need for blood transfusion,side effects and cost -efectiveness of the drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •women undergoing elective or emergency caesarean section.
排除标准
- •Antepartum Haemorrhage,Severe Preeclampsia,Prolonged and Obstructed labour,Hb below 8gm/dl,Multiple Pregnancy,Polyhydramnios and associated Myoma of uterus,Cardiovascular,renal ,hepatic and connective tissue disorders.
结局指标
主要结局
blood loss during operation and 8 hours postpartum and change in the hemoglobin 24 hours after delivery.
时间窗: Blood loss:during operation and upto 8 hours postpartum. | Hb :predelivery and 24 hours after delivery.
次要结局
- need for additional uterotonic, incidence of side effects and complications, need for blood transfusion and cost of oxytocic.(Upto 24 hours postpartum.)
研究者
研究点 (1)
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