NCT02486679Unknown4 期
Cervical Ripening at Term With Prostaglandin E2 Tablets Versus Foley Catheter: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to active labor
研究概览
简要总结
A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton term pregnancies (>37 weeks), vertex presentation
- •Intact membranes
- •Low Bishop score (<7)
- •First, second or third delivery
- •Medical indication for induction
- •Viable fetus
排除标准
- •Contraindication for vaginal delivery, for PGE2 or foley catheter
- •Gestational age<37 weeks, premature rupture of membranes, fetal or uterine malformations, previous cesarean section, uncertain dating, unwilling to participate in trial
研究组 & 干预措施
PGE2
Active Comparator
Patients allocated to vaginal PGE2 (Prostin) for cervical ripening
干预措施: Prostin (PGE2) tablets (Drug)
Foley catheter
Active Comparator
Patients allocated to foley catheter placement for cervical ripening
干预措施: Foley catheter (Device)
结局指标
主要结局
Time to active labor
时间窗: Post labor- up to 24 hours
Hours from foley cather placement or first PGE2 tablet placment to active labor, defined as cervical dilitation \>4 cm and/or cervical effacement\>80%
次要结局
- Delivery within 24 hours(post-labor - up to 24 hours)
- Neonatal complications(Neonates of participants will be followed for labor course and the duration of hospital stay, up to 1 month)
- Cesarean section rate(post labor - up to 24 hours)
- Maternal complications(participants will be followed for labor course and the duration of hospital stay, an expected average of 5 days)
研究者
Hadas Ganer Herman
MD
Wolfson Medical Center
研究点 (1)
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