NCT03148574已完成3 期
Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery to Reduce Intraoperative and Postoperative Blood Loss: A Randomized Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- amount of intraoperative blood loss
研究概览
简要总结
Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with emergency hysterectomy
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1-Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins.
- •3-Had no history of coagulopathy. 4-Accepting to participate in the study.
排除标准
- •\1-women with anemia (Haemoglobin <8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption )
- •History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy
研究组 & 干预措施
misoprostol
Experimental
intrauterine 400 microgram
干预措施: Misoprostol (Drug)
oxytocin
Active Comparator
intravenous infusion 10 units
干预措施: Oxytocin (Drug)
结局指标
主要结局
amount of intraoperative blood loss
时间窗: 30 minutes
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
principal investigator
Assiut University
研究点 (1)
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