Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NOFOX): a Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 2
- 主要终点
- Delivery Rate
研究概览
简要总结
The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for induction of labor will increase the rate of delivery within 24 hours stratified by parity.
详细描述
This is a multi-center, open-label, randomized study. Women with a singleton, vertex gestation between 24-42 weeks gestations presenting for labor induction will be offered participation in this study. Patients who receive prenatal care at Christiana Care may be approached if an induction of labor is scheduled and consented at their prenatal visit. All indications for induction will be included except those specifically mentioned as exclusion criteria. Any contraindication for vaginal delivery would exclude the subject. After informed consent is obtained, the Foley catheter will be placed and the subject will be randomized to receive oxytocin (study group) or not (control group). After Foley catheter removal or expulsion, the remainder of the induction course was left to the discretion of the primary provider. Prior to randomization, the subject will be placed into the nulliparous or multiparous group.
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
- •Age greater than 18 years
- •Pregnant, singleton gestation, vertex presentation
- •Admitted for induction of labor between gestational ages 24 - 42 weeks
- •Bishop score <6
排除标准
- •Multiple gestation
- •Non-vertex presentation
- •Latex allergy or latex-free Foley catheter to be placed
- •Fetal death
- •Anomalous fetus
- •Placenta/vasa previa
- •Placental abruption (known or suspected)
- •Intrapartum bleeding
- •Non-reassuring fetal tracing with following criteria: category III tracing, OR minimal variability AND decelerations of any kind, OR late decelerations occurring >50% of contractions
- •2 or more previous cesarean section, myomectomy, or classical cesarean
- •Need to use ripening agents prior to Foley placement
- •Spontaneous labor
- •Active genital herpes
- •Inability to consent
- •Any contraindication to a vaginal delivery
研究组 & 干预措施
Nulliparous - Foley only
Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
干预措施: Transcervical Foley catheter (Device)
Nulliparous - Foley and oxytocin
Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
干预措施: Oxytocin (Drug)
Nulliparous - Foley and oxytocin
Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
干预措施: Transcervical Foley catheter (Device)
Multi(primi)parous - Foley only
Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
干预措施: Transcervical Foley catheter (Device)
Multi(primi)parous - Foley and oxytocin
Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
干预措施: Oxytocin (Drug)
Multi(primi)parous - Foley and oxytocin
Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
干预措施: Transcervical Foley catheter (Device)
结局指标
主要结局
Delivery Rate
时间窗: Within 24 hours
The rate of women who deliver in less than or equal to 24 hours from Foley placement.
次要结局
- Number of Participants With Time to Delivery Achieved Within 12 Hours(Within 12 hours)
- Total Time to Delivery(On average, 24-36 hours)
- Time to Foley Expulsion(0-12 hours)
- Number of Vaginal Deliveries(Assessed after delivery, on average occurring between 24-48 hours)
- Regional Analgesia(Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours)
- Obstetric Complications(Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period)
- Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7(Assessed from birth through discharge, on average 2 days after birth)
- Neonatal Outcome: Neonatal Weight(Assessed from birth through discharge, on average 2 days after birth)
研究者
Corina Schoen
Maternal Fetal Medicine Fellow
Christiana Care Health Services