Comparison of Labor Induction With Cervical Ripening Balloon, One Versus Tweleve Hours Placement: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 164
- 主要终点
- insertion to delivery time interval
研究概览
简要总结
The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery.
Women admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.
详细描述
The common IOL techniques used for pregnant women with unfavorable cervix might be specified to either mechanical induction via cervical ripening balloon (CRB) or pharmacological induction. The insertion of a CRB is believed to mechanically ripen the uterine cervix with a better safety profile than prostaglandins. The duration of the balloon placement varied considerably, and it was commonly placed for 12-24 hours. Nevertheless, recent randomized controlled studies have demonstrated favorable results following only 6 hours of CRB placement with or without additional administration of oxytocin. We believe that mechanical ripening of the cervix can be achieved even less than six hours. Our study aims to evaluate the time to delivery and pregnancy outcomes after placement of CRB of only 1 hour compared to either 6 or 12 hours.
Study Protocol:
- Women planned for induction of labor will be approached by a trained resident and will sign informed consent.
- All participants will be randomized to either one hour or twelve hours CRB placement using a computer program randomization scheme, block size of 20, by the department research coordinator who will keep the sequential in sealed envelopes.
- Demographic parameters will be retrieved from the computerized database of Rambam Medical Center (RMC).
- Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and after twelve hours in the control group. Thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous or multiparous gravidas
- •Gestational age ≥ 370/7 to 416/7 gestational weeks
- •Signed informed consent
排除标准
- •Contraindications for vaginal delivery
- •Multifetal gestation
- •Rupture of membranes
- •Bishop score > 6
- •The cervix is dilated to more than 2 cm
- •Previous caesarean delivery
结局指标
主要结局
insertion to delivery time interval
时间窗: From date of balloon insertion until the date of delivery, assessed up to 4 days
The time interval between balloon insertion to delivery
次要结局
- to compare the rate of anal sphincter injuries(From date of balloon insertion until the date of discharge, assessed up to 8 days)
- to compare the mode of delivery(From date of balloon insertion until the date of delivery, assessed up to 4 days)
- to compare the rate of chorioamnionitis(From date of balloon insertion until the date of discharge, assessed up to 8 days)
- to compare the need for blood transfusion(From date of balloon insertion until the date of discharge, assessed up to 8 days)
- To compare the length of maternal hospital stay(From date of balloon insertion until the date of discharge, assessed up to 8 days)
- to compare the time to active and second stage of labor(From date of balloon insertion until the date of delivery, assessed up to 4 days)
- to compare the rate of post-partum hemorrhage(From date of balloon insertion until the date of discharge, assessed up to 8 days)
- To compare the rate of neonatal acidemia between the groups(From date of delivery until the date of neonate discharge, assessed up to 14 days)
- To compare the overall satisfaction rate(From date of balloon insertion until the date of discharge, assessed up to 8 days)
- To compare the Apgar score between the groups(at the date of delivery)
- To compare the rate of admission to neonatal intensive care unit between the groups(From date of delivery until the date of neonate discharge, assessed up to 14 days)
- To compare the rate of Respiratory complications between the groups(From date of delivery until the date of neonate discharge, assessed up to 14 days)
- To compare the rate of neonatal sepsis between the groups(From date of delivery until the date of neonate discharge, assessed up to 14 days)
- To compare the rate of birthweightbetween the groups(at the date of delivery)