Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 509
- 试验地点
- 1
- 主要终点
- Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol
研究概览
简要总结
This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia
详细描述
The third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. A randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with a singleton pregnancy, delivered vaginally
- •28 weeks of gestation and more,
- •had a prolonged third stage of labor (more than 30 minutes) despite active management,
- •Haemodynamically stable and accept to participate in the trial
排除标准
- •multiple pregnancies,
- •previous caesarean delivery,
- •haemodynamically instability, severe anaemia (haemoglobin concentration <8 g/dL),
- •chorioamnionitis
- •Refused to participate in the trial
研究组 & 干预措施
400 Microgram Misoprostol
Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group
干预措施: Misoprostol (Drug)
800 Microgram Misoprostol
Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group
干预措施: Misoprostol (Drug)
结局指标
主要结局
Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol
时间窗: up to 30 minutes after intraumbilical injection
complete delivery of placenta after injection of intraumbilical misoprostol
次要结局
- side effects of misoprostol(up to 24 hours after delivery of placenta)
- The amount of blood loss vaginally in both groups(up to 30 minutes after injection of placenta)
- The time of delivery of placenta in both groups(up to 30 minutes after delivery of the placenta)
研究者
Shahla Alalaf
Professor Shahla K.Alalaf
Hawler Medical University