Early Versus Delayed Artificial Rupture of Membranes Following Foley Catheter Ripening in Labor Induction: A Randomized Controlled Trial (AROM Trial)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- time to delivery
研究概览
简要总结
This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy.
This project will include 157 women presenting at Christiana Care Health System. 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 combined with either misoprostol or pitocin. Following admission, women will be randomized into either early or delayed amniotomy
Women will be randomized with equal probability to the intervention group using block randomization stratified by party.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •full term (≥37 weeks) gestations determined by routine obstetrical guidelines
- •singleton gestation in cephalic presentation
- •Both nulliparous and multiparous women
- •Intact membranes
- •Bishop score of ≤6 and cervical dilation ≤2cm
排除标准
- •Any contraindication to a vaginal delivery or to misoprostol
- •fetal demise
- •Multifetal gestation
- •major fetal anomaly
- •prior uterine surgery, previous cesarean section
- •women with HIV, hepatitis C, hepatitis B, and women with medical conditions requiring an assisted second stage
- •Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies.
研究组 & 干预措施
Early Amniotomy
Women in the Early AROM group will under amniotomy one hour from Foley Catheter expulsion. Labor augmentation will continue per study protocol. Refer to Appendix A for protocol regimen.
干预措施: amniotomy (Procedure)
Early Amniotomy
Women in the Early AROM group will under amniotomy one hour from Foley Catheter expulsion. Labor augmentation will continue per study protocol. Refer to Appendix A for protocol regimen.
干预措施: Foley Catheter (Device)
Early Amniotomy
Women in the Early AROM group will under amniotomy one hour from Foley Catheter expulsion. Labor augmentation will continue per study protocol. Refer to Appendix A for protocol regimen.
干预措施: Misoprostol (Drug)
Delayed Amniotomy
Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given.
干预措施: amniotomy (Procedure)
Delayed Amniotomy
Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given.
干预措施: Foley Catheter (Device)
Delayed Amniotomy
Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given.
干预措施: Misoprostol (Drug)
结局指标
主要结局
time to delivery
时间窗: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery.
次要结局
- Blood transfusion(through study completion, an average of 1 year)
- Time to vaginal delivery(At time of delivery)
- Indication for cesarean delivery(At time of delivery)
- Cesarean delivery rate(At time of delivery)
- 3rd/4th degree perineal laceration(at time of delivery)
- Chorioamnionitis(At time of delivery)
- Wound separation-infection(through study completion, an average of 1 year)
- Neonatal death(through study completion, an average of 1 year)
- Maternal length of stay(through study completion, an average of 4 days)
- Endometritis(From time of delivery to time of hospital discharge; up to 6 weeks)
研究者
Helen Beatriz Gomez
Resident Physician
Christiana Care Health Services