NCT01596296已完成不适用
Foley Catheter Versus Dinoprostone Vaginal Insert for Induction of Labor in Parous Women at Term: A Randomized Trial
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
- Successful labor induction
研究概览
简要总结
The purpose of this study is to assess the effectiveness and safety of transcervical foley catheter as compared to dinoprostone vaginal insertion for preinduction cervical ripening and labor induction in term parous women with 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
- •parous women
- •gestational age >=37.0 weeks
- •Bishop score <=5
- •intact amniotic membrane
- •absence of labor
- •live fetus with vertex presentation
- •no previous uterine surgical procedure
排除标准
- •major congenital anomaly
研究组 & 干预措施
Transcervical foley catheter
Active Comparator
干预措施: Transcervical foley catheter (Device)
Dinoprostone
Active Comparator
干预措施: Dinoprostone 10mg (Drug)
结局指标
主要结局
Successful labor induction
时间窗: Twelve hours of initiating oxytocin on the first day of induction
Successful labor induction is defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of \>=4cm.
次要结局
- Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and dinoprostone vaginal insertion(When transcervical foley catheter or dinoprostone was removed before adminitoring oxytocin)
研究者
研究点 (1)
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