Labor Induction After Cesarean: A Randomized Trial Of Cervical Balloon With or Without Oxytocin
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time to delivery
研究概览
简要总结
A randomized trial of patients undergoing a term (≥37 weeks) induction of labor with a history of one prior Cesarean delivery, wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing Foley alone with concurrent Foley and Oxytocin use at the start of the induction. With this trial, the investigators aim to test our central hypothesis that concurrent Foley and Oxytocin will decrease time to delivery without increasing risks, compared to Foley alone.
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
- •Eligible for induction of labor
- •Live singleton gestation ≥37 weeks
- •History of 1 cesarean delivery
- •≥18 years of age
- •Cephalic presentation
- •Intact membranes
- •English or Spanish speaking (Able to read/understand consent and instructions)
- •Cervical dilation <3cm and Bishop score <8
排除标准
- •>1 prior Cesarean delivery
- •Known chorioamnionitis
- •Major fetal anomaly
研究组 & 干预措施
Foley balloon alone
Cervical ripening will begin with a Foley balloon alone. Oxytocin will not be started until the balloon is removed or expelled, though can be considered if the balloon remains in place for >8 hours
干预措施: Foley balloon (Device)
Concurrent Foley balloon and Oxytocin
Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement
干预措施: Foley balloon (Device)
Concurrent Foley balloon and Oxytocin
Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement
干预措施: Oxytocin (Drug)
结局指标
主要结局
Time to delivery
时间窗: At delivery
The primary endpoint will be time from start of induction until delivery (hours)
次要结局
- Number of Participants with Uterine Rupture(At delivery)
- Estimated postpartum blood loss(At delivery)
- Postpartum hemorrhage(Within 6 weeks of delivery)
- Number of Participants with Chorioamnionitis(At delivery)
- Mode of delivery(At delivery)
- Maternal morbidity(Within 6 weeks of delivery)
- Neonatal morbidity(Within 6 weeks of delivery)
- Maternal length of stay(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- Neonatal length of stay(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- NICU stay greater than 48 hours(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)(From time of delivery to discharge from hospital, up to 6 weeks from delivery)
- Mode of delivery(At delivery)
- Estimated postpartum blood loss(At delivery)
- Postpartum hemorrhage(Within 6 weeks of delivery)
- Maternal morbidity(Within 6 weeks of delivery)
- Neonatal morbidity(Within 6 weeks of delivery)
- Maternal length of stay(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- Neonatal length of stay(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- NICU stay greater than 48 hours(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)(From time of delivery to discharge from hospital, up to 6 weeks from delivery)
研究者
Lisa Levine
Associate Professor
University of Pennsylvania