A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- induction time to delivery
研究概览
简要总结
This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.
Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed.
After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).
详细描述
Currently there is a paucity of literature to determine the efficacy of use of Pitocin during Foley placement, a single study has been published which suggests that the induction to delivery time is shortened in multiparas, but not in nulliparas. This study was not specifically powered to assess nulliparas as well, without increased risk.
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
- 是
入选标准
- •women at > 24 weeks gestation
- •a non-anomalous, singleton fetus in a vertex presentation
排除标准
- •history of prior uterine surgery such as cesarean section or myomectomy
- •unexplained vaginal bleeding
- •latex allergy
- •contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)
研究组 & 干预措施
Oxytocin
Use of oxytocin while the Foley bulb is in place
干预措施: Oxytocin (Drug)
PROMS Foley and oxytocin
Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed.
干预措施: Oxytocin (Drug)
结局指标
主要结局
induction time to delivery
时间窗: Time from induction to delivery, average 12-28 hours
The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate.
次要结局
- uterine atony(average of 12-28 hours from induction until official time of birth)
- Mode of delivery(average of 12-28 hours from induction until official time of birth)
- estimated blood loss(average of 12-28 hours from induction until official time of birth)
- neonatal birthweight(average of 12-28 hours from induction until official time of birth)
- chorioamnionitis(average of 12-28 hours from induction until official time of birth)
研究者
Angela Bianco
Associate Professor
Icahn School of Medicine at Mount Sinai