Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Vaginal delivery within 24 hours
研究概览
简要总结
To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for nulliparas at term with an unfavorable cervix
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton pregnancy
- •Nulliparous women
- •gestational age >=37.0 weeks
- •Bishop score <=6
- •intact amniotic membrane
- •absence of labor
- •live fetus with vertex presentation
- •no previous uterine surgical procedure
排除标准
- •Multiple pregnancy
- •Placenta previa
研究组 & 干预措施
Oxytocin & Membrane sweeping
Women assigned to "Concurrent oxytocin with membrane sweeping" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, followed by oxytocin infusion the next day
干预措施: Oxytocin (Drug)
Oxytocin & Membrane sweeping
Women assigned to "Concurrent oxytocin with membrane sweeping" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, followed by oxytocin infusion the next day
干预措施: Membrane sweeping (Procedure)
Oxytocin & Dinoprostone
For women assigned to "Concurrent oxytocin with dinoprostone vaginal insert": The 10mg dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening, followed by oxytocin infusion the next day
干预措施: Oxytocin (Drug)
Oxytocin & Dinoprostone
For women assigned to "Concurrent oxytocin with dinoprostone vaginal insert": The 10mg dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening, followed by oxytocin infusion the next day
干预措施: Dinoprostone (Drug)
结局指标
主要结局
Vaginal delivery within 24 hours
时间窗: From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of vaginal delivery, assessed up to 24 hours
Vaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) on the first day of induction.
次要结局
- Incidence of cesarean delivery(End of labor induction (assessed up to 120 hours))
- Successful labor induction(From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of active phase of labor ( defined as a cervical dilatation of >=4cm), assessed up to 24 hours)
- The interval from start of oxytocin to delivery(From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours)
研究者
Kyo Hoon Park, MD
Professor
Seoul National University Hospital