NCT01190163终止4 期
Phase IV, Multicenter, Open Label, Randomized Trial to Compare the Effectiveness and Safety of the Dinoprostone Vaginal Pessary vs. Oxytocin for Women Requiring Cervical Ripening Prior to Induction of Labor
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 170
- 试验地点
- 4
- 主要终点
- Vaginal birth delivery within 24 hours and C-section rate
研究概览
简要总结
This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •Gestational age ≥ 38 weeks
- •Fetal cephalic presentation
- •Bishop score < 6
排除标准
- •No uterine scar (no previous delivery by caesarean section)
- •No more than 3 previous vaginal births
- •No condition that disallows use of prostaglandins for induction of labor
- •Premature rupture of the membranes
- •Oligohydramnios
研究组 & 干预措施
A
Experimental
干预措施: Dinoprostone (Drug)
B
Active Comparator
干预措施: Oxytocin (Drug)
结局指标
主要结局
Vaginal birth delivery within 24 hours and C-section rate
时间窗: 24 hours
次要结局
- Treatment failure rate(24 hours)
- Uterine hyperstimulation and/or fetal distress(24 hours)
- Use of additional oxytocin(24 hours)
研究者
研究点 (4)
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