Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Time to Active Phase of Labor
研究概览
简要总结
Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.
详细描述
This will be an unblinded randomized clinical trial. The investigators will recruit 174 pregnant women undergoing induction of labor. Recruitment will occur on the Labor and Delivery unit at the time of induction, after the decision has been made to place a Foley balloon for cervical ripening. Enrolled subjects will be randomized to early or delayed amniotomy.
Subjects randomized to early amniotomy will undergo amniotomy within 2 hours of Foley balloon removal. Subjects randomized to delayed amniotomy will undergo amniotomy at least 4 hours after Foley balloon removal.
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
- •Singleton pregnancy
- •Term gestation (37 weeks gestation)
- •Cephalic presentation
- •Undergoing labor induction with transcervical Foley balloon
排除标准
- •Previous uterine surgery
- •Prelabor rupture of membranes
- •Severe pre-eclampsia, HELLP, or eclampsia
- •HIV, HCV, or HBV
- •Heart disease
- •Fever (≥38 0C) at admission
- •Category II or III fetal heart rate tracing prior to randomization
- •Polyhydramnios
- •Fetal growth restriction <3%
- •EFW > 4200 g
- •Fetal demise or major congenital anomaly
- •Prisoners
结局指标
主要结局
Time to Active Phase of Labor
时间窗: At delivery
Total time from initiation of labor induction to reaching 6 cm cervical dilation
次要结局
- Time to Delivery(At delivery)
- Vaginal Delivery Rate(At delivery)
- Cesarean Section Rate(At delivery)
- Maternal Infection Composite(From admission to discharge, up to 2 weeks)
- Umbilical Cord Prolapse(At delivery)
- Neonatal Outcome Composite(From admission to discharge, up to 2 weeks)