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临床试验/NCT02618096
NCT02618096已完成不适用

Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Multiparous Women at Term

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
1
主要终点
Vaginal delivery within 24 hours

研究概览

简要总结

The purpose of this study is to compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for multiparas 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

入选标准

  • singleton pregnancy
  • Multiparous 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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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. membrane sweeping or 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. membrane sweeping or 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. membrane sweeping or 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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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