A Prospective, Randomized Comparison of Tension Versus no Tension With Foley Transcervical Catheters for Pre-induction Cervical Ripening
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Time to Delivery
研究概览
简要总结
To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.
详细描述
Patients who are scheduled to undergo labor induction will be offered inclusion in the study which will attempt to determine if placing tension on the foley ballon will shorten the interval between induction initiation and delivery.
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
- •Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children.
- •Cephalic presentation
- •Intact fetal membranes
- •Bishop score less than or equal to 6
- •Age greater than or equal to 18 years
排除标准
- •Multiparas
- •Multiple gestation
- •Previous uterine/cervical surgery
- •Ruptured fetal membranes
- •Fetal malpresentation
- •Any contraindication to vaginal delivery at time of admission
研究组 & 干预措施
Tension
foley balloon will be placed on tension and taped to thigh at 10 cm. Misoprostil will be placed in posterior vaginal vault.
干预措施: Tension (Procedure)
No tension
The foley balloon will be loosely taped without tension to the patient's thigh. Misoprostil will be placed in the posterior vaginal vault.
干预措施: NO TENSION (Procedure)
结局指标
主要结局
Time to Delivery
时间窗: Will measure length of time from beginning of induction with the foley balloon until delivery
Reduction in time to delivery
次要结局
未报告次要终点
研究者
Holly Olson
Assistant Professor
Hawaii Pacific Health