Foley Catheter Versus Oxytocin for Labor Induction in Women With Term and Near Term Premature Rupture of Membranes: A Randomized Clinical Trial (FOLCROM Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 5
- 主要终点
- Time From Induction of Labor Until Delivery
研究概览
简要总结
Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.
详细描述
This is a prospective, randomized, multi-center clinical trial to test the hypothesis that in women with term and near term premature rupture of membranes (PROM), an intrauterine Foley catheter plus oxytocin infusion will decrease the mean time from induction to delivery by 2.5 hours as compared to oxytocin 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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Spontaneous rupture of membranes (ROM) ≥1 hour prior to starting induction; ROM defined as clinical history with the presence of 2 of the following 4: pooling, ferning, nitrazine, oligohydramnios. In the absence of clinical history, oligohydramnios AND pooling must be present for ROM to be diagnosed. Oligohydramnios is defined as a total amniotic fluid index of <5cm or a maximum vertical pocket <2cm.
- •Unfavorable cervix, defined as sterile digital exam ≤ 2cm dilated / 80% effaced
- •Gestational age ≥ 34 weeks by best obstetric estimate
- •Clinical management decision is vaginal delivery
- •Singleton gestation
- •Cephalic presentation
- •Willing to participate and able to understand and sign the informed consent document before randomization
- •Women of reproductive age
排除标准
- •Multiple gestations
- •Lethal fetal anomalies, e.g., anencephaly, trisomy 13, trisomy 18
- •Latex allergy
- •Greater than 1 prior cesarean delivery
- •Active labor - defined as contractions more frequent than every 5 minutes (or ≥ 12 contractions in 1 hour) associated with ≥ 1 cm cervical change. In the absence of ≥ 1 cm cervical change after 2 hours, patients with contractions can be included in the study.
- •Suspicion of chorioamnionitis
- •Any contraindications to vaginal delivery, including malpresentation, active herpes, complete placenta previa, greater than two prior cesarean deliveries, etc.
- •HIV positive status or AIDS
- •Intrauterine fetal demise
- •Suspected placental abruption, significant hemorrhage
- •Nonreassuring fetal heart rate (FHR) pattern
- •Participation in a competing trial
研究组 & 干预措施
Oxytocin
This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
干预措施: Oxytocin (Drug)
Foley Catheter and Oxytocin
A 30cc/16 French (16F) foley catheter will be inserted by the provider under direct visualization or by palpation, ensuring that the catheter is appropriately and adequately positioned. Oxytocin will be administered concurrently at a rate of 2 milliunits/milliliter (as noted under oxytocin active comparator). If the catheter remains in place after 12 hours, it will be deflated and removed and oxytocin infusion will continue.
干预措施: Foley Catheter (Device)
Foley Catheter and Oxytocin
A 30cc/16 French (16F) foley catheter will be inserted by the provider under direct visualization or by palpation, ensuring that the catheter is appropriately and adequately positioned. Oxytocin will be administered concurrently at a rate of 2 milliunits/milliliter (as noted under oxytocin active comparator). If the catheter remains in place after 12 hours, it will be deflated and removed and oxytocin infusion will continue.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Time From Induction of Labor Until Delivery
时间窗: Time from induction to delivery (average 14.2 hours)
Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries
次要结局
- Number of Participants With Chorioamnionitis(Duration of Labor (average 4.8 hours))
- Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin(Duration of Labor (average 4.8 hours))
- Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin(Duration of Labor (average 4.8 hours))
- Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries(Duration of Labor (average 4.8 hours))
- Rate of Failed Induction of Labor as the Indication for Cesarean(Duration of Labor (average 4.8 hours))
- Rate of Endomyometritis(Duration of hospital stay (average 3.4 days))
- Maternal Length of Stay, From Admission to Discharge (Days)(Duration of hospital stay (average 3.4 days))
- Rate of Five Minute Apgar Score < 5(Duration of hospital stay (average 3.4 days))
- Arterial Cord Blood Gas (pH), When Obtained(Within 1 hour of delivery)
- Rate of Neonatal Sepsis(Duration of hospital stay (average 3.4 days))
- Neonatal Intensive Care Unit (NICU) Admission Rate(Duration of hospital stay (average 3.4 days))
- Neonatal Length of Stay(Duration of hospital stay (average 3.4 days))
- Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis(Duration of hospital stay (average 3.4 days))
- Time From Induction to Delivery (Hours)(Time from induction to delivery (average 14.2 hours))
- Overall Cesarean Delivery(Duration of hospital stay (average 3.4 days))
- Rate of Chorioamnionitis(Duration of hospital stay (average 3.4 days))
- Maternal Length of Stay From Delivery to Discharge (Hours)(Duration of hospital stay (average 3.4 days))