Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- Rate of vaginal delivery <24 hours
研究概览
简要总结
To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety.
详细描述
This study is a non-blinded, three arm randomized trial at 3 sites. Entry criteria were: >36 weeks' singleton, cephalic gestation with intact membranes and an unripe cervix (Bishop's score <6). Study arms were: 1) dinoprostone vaginal insert (Cervidil) for 12 hours followed by oxytocin, 2) dinoprostone vaginal insert (Cervidil) for 12 hours with simultaneous oxytocin, and 3) intracervical dinoprostone gel (Prepidil)(one dose) followed by immediate oxytocin. Primary outcome measure was the rate of vaginal delivery <24 hours. Secondary outcomes were randomization to delivery interval, rate of cesarean delivery (CD) for non reassuring fetal status (NRFS) and rate of uterine hyperstimulation.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> or = to 36 weeks of gestation
- •Singleton fetus
- •Cephalic presentation
- •Intact membranes and an unripe cervix (Bishop score <6)
排除标准
- •Multifetal gestation
- •Rupture of membranes
- •Ripe cervix (Bishop score >6)
- •Active labor
- •Contraindication to vaginal delivery
- •Previous uterine surgery
- •Non-cephalic presentation
- •Fetal macrosomia
结局指标
主要结局
Rate of vaginal delivery <24 hours
次要结局
- Randomization to delivery interval
- Rate of cesarean delivery for non reassuring fetal status
- Rate of uterine hyperstimulation