Double Foley Catheter For Ripening The Unfavorable Cervix: An Alternative Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- vaginal delivery within 24 hours
研究概览
简要总结
To compare the efficacy of three mechanical devices for pre-induction of labour cervical ripening: the Single Foley Catheter, Double Foley Catheter (a new handmade device) and Cook cervical ripening balloon.
详细描述
This prospective study Scheduled included 74 Double Foley Catheter, 74 Single Foley catheter group and 74 Cook cervical ripening catheter group. All pregnant women will be randomly allocated into three groups: the single Foley, Double Foley Catheter or Cook balloon catheter. Removal of the catheters is planned approximately 12 h after insertion if spontaneous expulsion occurred. The main outcome measures include changes in Bishop score, insertion to delivery time, mode of delivery and occurrence of adverse effects.
Double Foley Catheter is a new method for cervical ripening that Two 18-Fr Foley catheters are connected with sterile suture from the hole end and where the balloons borders end. Both catheters are pushed above the internal cervical os the uterus. One of 18-Fr Foley catheter full with 80 mL of normal saline. The other Foley catheter is pulled into the vagina by applying traction and full with 80 mL of normal saline. The cervix between two balloons of Foley catheters exposed to pressure from both sides from the Foley catheter's balloon's similar to Cook balloon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with term pregnancy,
排除标准
- •Breech presentations, previous cesarean section, Cephalopelvic disproportion, previous uterine scars, estimated fetal weight above 4500
结局指标
主要结局
vaginal delivery within 24 hours
时间窗: 24 hours
the time from applying catheter to delivery
pain score
时间窗: 36 hours
The pain score during ripening phase which a visual analog scale is completed by the study population to assess the pain score during the entire ripening periods. The pain scores were assessed using the visual analog scale (where 0 = no pain and 10 = worst possible pain).
ripening success
时间窗: 12 hours
Calculated soon after removal or spontaneous expulsion of catheters above 6 or increasing 2 point above baseline bishop score
次要结局
未报告次要终点
研究者
Mehmet Obut
Medical Doctor
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital