A Randomized Clinical Trial of Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Time interval from Foley catheter removal to delivery
研究概览
简要总结
Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least 4 hours after Foley catheter removal). Other aims include the relationship between timing of amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar score <7 at 5 minutes, neonatal need for intensive care.
The investigators hypothesize that induction of labor with Foley catheters followed by early amniotomy will result in a decreased duration of labor compared to those who undergo delayed amniotomy.
详细描述
This randomized clinical trial of consenting nulliparous women undergoing induction of labor with a Foley catheter seeks to determine whether use of early amniotomy (defined as amniotomy within 1 hour of Foley catheter removal) improves obstetrical outcomes when compared with delayed amniotomy (defined as amniotomy at least 4 hours following Foley catheter removal).
This project will include 110 women recruited from the obstetrical service at Prentice Women's Hospital. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter. Following removal of Foley catheter, women will be assessed for safety of amniotomy and if appropriate, randomized to either early amniotomy or delayed amniotomy.
Women will be randomized with equal probability to the intervention group using block randomization stratified by use of Foley catheter alone or Foley catheter-misoprostol use.
Women in the early amniotomy group will undergo amniotomy within 1 hour of Foley catheter removal. Women in the delayed amniotomy group will undergo amniotomy at least 4 hours following Foley removal. The remainder of labor management will be at the discretion of each woman's obstetric provider.
Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
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
- •Able to provide informed consent
- •English speaking
- •Women age 18 years old or greater
- •Nulliparous
- •Pregnant with a singleton gestation that is greater than or equal to 37 weeks
- •Undergoing induction of labor with Foley catheter
排除标准
- •Women not meeting above criteria
- •Fetus in non-cephalic position
- •Intrauterine fetal demise
- •Fetus with major anomalies
- •HIV, hepatitis B or C infection
- •Planned use of oxytocin during the Foley catheter ripening
研究组 & 干预措施
Early Amniotomy
Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy within 1 hour of Foley catheter removal.
干预措施: Amniotomy (Procedure)
Early Amniotomy
Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy within 1 hour of Foley catheter removal.
干预措施: Foley Catheter (Device)
Early Amniotomy
Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy within 1 hour of Foley catheter removal.
干预措施: Misoprostol (Drug)
Delayed Amniotomy
Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy no sooner than 4 hours following removal of Foley catheter.
干预措施: Amniotomy (Procedure)
Delayed Amniotomy
Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy no sooner than 4 hours following removal of Foley catheter.
干预措施: Foley Catheter (Device)
Delayed Amniotomy
Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy no sooner than 4 hours following removal of Foley catheter.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Time interval from Foley catheter removal to delivery
时间窗: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
Hours
次要结局
- Cesarean delivery(At time of delivery)
- Chorioamnionitis(From time of admission to Labor and Delivery unit to delivery of neonate; up to 72 hours)
- Postpartum Fever(From time of delivery to time of hospital discharge; up to 6 weeks)
- Wound infection(From time of delivery to time of hospital discharge; up to 6 weeks)
- Endometritis(From time of delivery to time of hospital discharge; up to 6 weeks)
- 5 minute Apgar Score less than 7 out of 10(5 minutes following delivery; 5 minutes of neonatal life.)
- Neonatal intensive care unit admission(From time of delivery to hospital discharge; up to 6 weeks)
- Suspected or confirmed neonatal sepsis(From time of delivery to hospital discharge; up to 6 weeks)
- Length of Labor(Time from placement of Foley catheter to time of delivery of neonate; up to 5 days)
- Postpartum hemorrhage(From time of delivery to time of hospital discharge; up to 6 weeks)
- Delivery time less than 24 hours(From time of placement of Foley catheter to time of delivery of neonate; within 24 hours.)
研究者
Emily Miller
Assistant Professor of Obstetrics and Gynecology
Northwestern University