Safety and Efficacy of Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Amount of bleeding
研究概览
简要总结
Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative treatment when Oxytocin isn't available. The aim of this study is to compare the safety and efficacy of Oxytocin and misoprostol for prevention of PPH.
详细描述
In a double blind randomized controlled trial 400 pregnant women who has vaginal delivery at Shariati hospital are assigned into two groups either to receive 20 unite oxytocin in 1000cc ringer and 2 placebo tablet or 400mcg oral misoprostol and 2cc normal saline in 1000cc ringer.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •were women with singleton pregnancy
- •with cephalic presentation
- •who had NVD spontaneously or by induction
排除标准
- •placenta previa
- •placental detachment
- •coagulation problems
- •previous CS
- •macrosomia
- •Polyhydramnios
- •and uncontrolled asthma
研究组 & 干预措施
Misoprostol
400µg oral misoprostol
干预措施: Misoprostol (Drug)
Oxytocin
20 IU oxytocin
干预措施: Oxytocin (Drug)
结局指标
主要结局
Amount of bleeding
时间窗: 1 hour
within 1 hours after delivery
次要结局
- Hematocrite decrease(24 hours)
- Hemoglobin decrease(24 hours)
研究者
Hamidreza Mahboobi
Dr
Hormozgan University of Medical Sciences