Comparison of Labor Induction With Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement: a Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Insertion-to-Delivery Time Interval
研究概览
简要总结
The goal of this clinical trial is to learn if a shorter duration of cervical ripening balloon (CRB) placement can reduce the time to delivery in pregnant women undergoing induction of labor.
The main questions it aims to answer are:
Does placing the cervical ripening balloon for 3 hours or less result in a shorter interval from insertion to delivery compared to the standard 12-hour placement?
Does a shorter 3-hour balloon placement lead to better pregnancy outcomes, fewer complications, and lower maternal discomfort?
Researchers will compare a group of participants who have the balloon removed after 3 hours to a control group who have the balloon removed after 12 hours to see if the shorter duration decreases the overall time to delivery.
Participants will:
Sign an informed consent and be randomized into one of the two groups (3 hours vs. 12 hours).
Undergo the standard procedure of a double-lumen Cook cervical ripening balloon insertion.
Have the balloon removed after approximately 3 hours or 12 hours depending on their assigned group.
Proceed with amniotomy or Pitocin use at the discretion of the labor and delivery physician.
Complete a Birth Satisfaction Scale questionnaire and have their maternal and neonatal health outcomes tracked from the hospital's database.
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
- 否
入选标准
- •Nulliparous or multiparous pregnant women.
- •Gestational age between 37 0/7 and 41 6/7 weeks of gestation.
- •Maternal age between 18 and 45 years.
- •Participant has provided signed informed consent.
排除标准
- •Presence of any contraindications for vaginal delivery.
- •Multifetal gestation.
- •Rupture of membranes prior to balloon insertion.
- •Favorable cervix, defined as a Bishop score greater than
- •Cervical dilation greater than 2 cm.
- •Previous cesarean delivery or any other prior major uterine surgery.
结局指标
主要结局
Insertion-to-Delivery Time Interval
时间窗: From the time of balloon insertion up to delivery (approximately 48 hours).
The time interval (in hours) from the successful insertion of the cervical ripening balloon to the time of fetal delivery (whether vaginal or cesarean section).
次要结局
- Duration of Hospitalization(From admission for induction up to hospital discharge (approximately 3-5 days).)
- Mode of Delivery(At the time of delivery.)
- Time to Active Phase and Second Stage of Labor(From balloon insertion up to delivery, assessed up to 48 hours after balloon insertion.)
- Maternal Complications(From balloon insertion up to 48 hours postpartum.)
- Adverse Neonatal Outcomes(From birth up to newborn discharge or 7 days of life.)
研究者
Bar Rosh MD
Resident
Rambam Health Care Campus