NCT02344459已完成不适用
Randomized Controlled Trial: Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- Bishop score greater than or equal to 6 at time of balloon catheter removal
研究概览
简要总结
The purpose of this study is to perform a randomized controlled trial to compare the efficacy of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction cervical ripening by evaluating the change in Bishop score.
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
- 是
入选标准
- •Bishop score of 5 or less
- •Singleton
- •Cephalic presentation
- •Fewer than 4 contractions in 10 minutes
- •Reactive fetal monitoring
排除标准
- •Non-vertex presentation
- •Placenta previa
- •Vasa previa
- •Unexplained vaginal bleeding
- •Active herpes simplex virus infection
- •Non-English speaking
- •Previous attempt at an induction of labor in the current pregnancy
- •Prolapsed umbilical cord
- •More than one prior cesarean delivery or history of classical cesarean delivery
- •Patients receiving or planning to undergo exogenous prostaglandin administration as the primary induction agent
结局指标
主要结局
Bishop score greater than or equal to 6 at time of balloon catheter removal
时间窗: until catheter removal (12 hours maximum)
次要结局
- Neonatal intensive care unit admissions(The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours))
- Meconium stained amniotic fluid(The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours))
- Cesarean section indications(The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours))
- vaginal delivery time less than 24 hours from initiation of induction(24 hours)
- mode of delivery(The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours))
- Epidural utilization(The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours))
- Artificial rupture of membranes required to augment labor(The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours))
- induction to delivery time(The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours))
- Time to catheter expulsion(Up to 12 hours)
- Type of catheter expulsion(The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours))
- 5 minute Apgar score(The participants infant will be monitored from immediately to 5 minutes after birth)
- Medication required to augment labor(The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours))
- birthweight(The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours))
- Chorioamnionitis(The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours))
研究者
Kara Hoppe
Maternal Fetal Medicine Fellow
University of Washington
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