Intra-umbilical Injection of Misoprostol Versus Normal Saline in the Management of Retained Placenta: Intrapartum Placebo-controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- delivery of placenta by medical intervention
研究概览
简要总结
Administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta and the amount of blood loss vaginally.
详细描述
Retained placenta (RP)is one of the complications of third stage of labour; it should be managed promptly as it may cause severe bleeding, infection, maternal morbidity and mortality .The current standard management of RP word wide, by manual removal aims to prevent these problems, but it is unsatisfactory method because it requires general anaesthesia in hospital, It is an invasive procedure with its own serious complications of bleeding, infection and genital tract injury. Umbilical vein injection of misoprostol is a simple, safe method and could be performed at the place of delivery .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •women having singleton pregnancy
- •28 weeks of gestation or more delivered vaginally
- •prolongation of the third stage of labour (more than 30 min) following active management of third stage of labour
排除标准
- •Who refused to participate in the trial
- •Multiple pregnancies
- •Previous Caesarean Section
- •Haemodynamically unstable
- •Severe anaemia (haemoglobin less than 8gm/dl)
- •Chorioamnionitis
研究组 & 干预措施
Misoprostol
4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein
干预措施: Misoprostol (Drug)
Normal saline
Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta
干预措施: Normal saline (Drug)
结局指标
主要结局
delivery of placenta by medical intervention
时间窗: 30 minutes after the injection of misoprostol or normal saline in the umbilical vein
The administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta under general anaesthesia.
次要结局
- vaginal bleeding after misoprostol use(30 minutes after umbilical vein injection of misoprostol)
研究者
Assistant Prof. Shahla Alalaf
Assistant Professor
Hawler Medical University