Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours. A Randomized Multicenter Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- time from insertion of the DBD to delivery
研究概览
简要总结
This study will evaluate the insertion of double balloon device (DBD) for cervical ripening for 12 h vs 6 hours.
详细描述
This randomized controlled study is designed to:
- To assess and compare the Bishop score when removing the DBD 12 hours' vs 6hours' after insertion.
- To compare the efficacy (vaginal delivery rate and time to VD) in the two arm groups
200 women are expected to be randomized in to two arms. One will be randomized to DBD removal after 12 hours and the other to DBD removal after 6 hours.
Each patient will sign an informed consent.
The following screening will be completed: medical and gynecological history, general physical and gynecological examination, ultrasonography to exclude contraindication to vaginal delivery or insertion if the DBD and non stress test (NST) for baseline. Bishop score will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Parous patients 18 years of age or older.
- •Diagnosed to be parous pregnant women with an indication for induction of labour.
- •Having a Bishop score of 5 or less.
- •Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of 37 completed gestational weeks or more.
- •Willingness to comply with the protocol for the duration of the study.
- •Have signed the informed consent.
排除标准
- •A non -vertex presentation
- •Placenta previa
- •Ruptured membranes
- •Documented labour
- •Foetal distress necessitating immediate intervention
- •Proven malignancy of the cervix
- •Active inflammatory or purulent condition of the lower genital tract
- •Twin pregnancy
- •Any other contraindication for vaginal delivery
研究组 & 干预措施
12 hours
This arm is the standard management that includes insertion of the DBD into the cervical canal according to manufacture guidelines, removal after 12 hours followed by artificial rupture of membranes and oxytocin infusion according to departments protocol. (a total of 10 units of oxytocin is infused, initiated with 10 cc/h, increased by 10cc every 20-30 min until 3-5 contractions are present, total of not more than 120 cc\h)
干预措施: cervical ripening device (Device)
6 hours
Removal of the DBD after 6 hours, followed by artificial rupture of membranes and oxytocin infusion according to departments protocol. (a total of 10 units of oxytocin is infused, initiated with 10 cc/h, increased by 10cc every 20-30 min until 3-5 contractions are present, total of not more than 120 cc\h)
干预措施: cervical ripening device (Device)
结局指标
主要结局
time from insertion of the DBD to delivery
时间窗: minutes or hours from insertion to delivery, assessed up to an estimated total of 24 hours
the time from insertion of the DBD until delivery will be assessed for each patient from each arm by hours/minutes
次要结局
- rate of vaginal delivery(1 year)
- maternal and neonatal adverse events(1 year)
研究者
Inna.bleicher
principle investigator Dr. Inna Bleicher
Bnai Zion Medical Center