A Randomized Controlled Trial of Foley Catheter for Labor Induction in Women With Term and Near Term Prelabor Rupture of Membranes (PROM)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 169
- 试验地点
- 3
- 主要终点
- Hours From Placement of Foley or Initiation of Oxytocin to Delivery
研究概览
简要总结
In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to decrease the time from the start of the induction to delivery.
详细描述
To compare the efficacy of a transcervical Foley catheter with concurrent oxytocin administration compared to oxytocin infusion alone for cervical ripening and labor induction in women with premature rupture of membranes (PROM) at > 34 weeks.
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
- 12 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Preterm rupture of membranes (PROM) (Rupture of membranes = pooling/ferning/nitrazine +) Rupture of membranes (ROM) for ≥1 hour prior to starting induction
- •Cervix ≤ 2 centimeters (cm)
- •Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery
- •Singleton gestation
- •Vertex well applied to cervix
排除标准
- •Regular uterine contractions (contractions more frequent than every 5 minutes)
- •Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor
- •Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
- •Lethal fetal anomalies
- •Intrauterine fetal demise (IUFD)
- •Suspected abruption/significant hemorrhage
- •Non-reassuring fetal heart rate (FHR) pattern
- •Non vertex fetal presentation
研究组 & 干预措施
Transcervical Foley Catheter
干预措施: Transcervical Foley catheter (Device)
No Foley
结局指标
主要结局
Hours From Placement of Foley or Initiation of Oxytocin to Delivery
时间窗: Time from induction to delivery
The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours)
次要结局
- Induction to Vaginal Delivery Interval(time from induction to vaginal delivery, up to 24 hours)
- Rate of Delivery (Vaginal or Cesarean)by 24 Hours(from start of induction to 24 hours post start of induction)
- Cesarean Rate(at delivery)
研究者
Alan Tita
Assoc Prof
University of Alabama at Birmingham