The Randomised-Controlled Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2.
研究概览
简要总结
Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.
详细描述
171 women with singleton term pregnancies and modified Bishop score (mBS) ≤ 5 were recruited and randomized into 3 arms: current dinoprostone regime, double dose misoprostol or single dose misoprostol. The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2. Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnancy, cephalic presentation, gestation greater than 37 completed weeks, no known contraindication to vaginal delivery, and Bishop score≤5.
排除标准
- •previous caesarean section or other uterine surgery, significant maternal medical/obstetric complication in pregnancy (such as severe pre-eclampsia, significant antepartum haemorrhage), antepartum evidence of fetal compromise (such as fetal growth restriction), previous attempt at cervical priming, contraindication to receiving prostaglandins, including asthma and glaucoma.
结局指标
主要结局
The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2.
次要结局
- Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome.