Phase 2-3 Study of Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Blood Loss at Cesarean Deliveries
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Intraoperative bleeding
研究概览
简要总结
The purpose of this study is to determine whether the effect of sublingual misoprostol is better than infusion oxytocin in reduction of blood loss at cesarean deliveries.
详细描述
A total of 180 pregnant women with gestational age 37 weeks and over who underwent cesarean operation in Imam Reza hospital had elective or emergency procedure with incision in lower segment during one year recruitment. The patients were randomly assigned to undergo 200 micrograms misoprostol sublingual or 400 micrograms and infusion 20 unit oxytocin after spinal anesthesia. Main outcome measures: The length of surgery, bleeding volume, the need for transfusion, fever, tachycardia, and hypotension.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 44 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Indication of Cesarean Deliveries
- •Elective or Emergency with Incision in Lower Segment in Women with
- •Gestational Age more than 37 Weeks.
排除标准
- •Multiple Pregnancy
- •Polyhydraminus
- •Prolonged Labor
- •Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus
- •Hypertension
- •Cardiovascular Disease
- •Coagulopathy Disease
研究组 & 干预措施
Misoprostol
干预措施: Misoprostol (Drug)
结局指标
主要结局
Intraoperative bleeding
时间窗: At the time of surgery
次要结局
- Fever(During 48 hours after surgery measured every 3 hours)
- Changing of pulse rate from base(Before surgery & intraoperative & 6 hours after surgery)
- Changing of blood pressure(Before surgery & intraoperative & 6 hours after surgery)
- Diarrhea(Before & 6 hours after surgery)
- Vomiting(Before & 6 hours after surgery)
研究者
Soudabeh Eshghi ali
Obstetrics & Gynecology Department
Kermanshah University of Medical Sciences