A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 592
- 主要终点
- Time from treatment start to delivery
研究概览
简要总结
This is a randomised study aimed at comparing the currently most frequently used prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and randomised to one of the three methods. The main outcome measures were time to delivery, rate of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol would be superior to the other methods.
The main finding of our trial was that the catheter showed the shortest induction to delivery interval. There were no differences between the two other prostaglandins. No differences in maternal and neonatal outcome was found
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Full term singleton pregnancy with vertex presentation and with an indication for labour induction.
- •Absence of active labour
- •Bishop score ≤
- •Normal CTG registration
排除标准
- •Previous cesarean section
- •signs of infection
- •immediate need for delivery
- •any contraindication for vaginal delivery
研究组 & 干预措施
1
Labour induction with misoprostol
干预措施: misoprostol (Drug)
2
Labour induction with dinoprostone
干预措施: dinoprostone (Drug)
3
Labour induction with bard
干预措施: Bard Catheter (balloon catheter) (Device)
结局指标
主要结局
Time from treatment start to delivery
时间窗: At delivery
次要结局
未报告次要终点