A Randomized Controlled Trial of Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time at readiness for discharge post-surgery
研究概览
简要总结
The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on time to ambulation, time to discharge, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.
详细描述
This would be a randomized controlled trial conducted on the labour and delivery and post-partum unit at a large academic site (Foothills Medical Centre) in Calgary, Alberta. Study recruitment of patients awaiting delivery via CS would occur either in participating prenatal clinics in Calgary or in obstetrical triage by a trained nurse research assistant. Participants would be randomized into either a catheterized or non-catheterized group prior to their scheduled elective CS. Allocation concealment will be ensured by using either a central computer generator for randomization if funding permits, otherwise sealed, opaque, and sequenced envelopes will be used. Since there may be potential differences in patients with increasing parity, randomization will be stratified by parity and blocked to prevent imbalance in treatment groups.
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
- •- women who are 18 years of age or older with a singleton pregnancy presenting for an elective primary or repeat CS.
排除标准
- •- diagnosis of abnormal placentation including placenta previa, vasa previa, or suspected invasive disease
研究组 & 干预措施
Bladder catheterization
Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post Cesarean section.
干预措施: Bladder catheterization (Procedure)
Non-use of bladder catheterization
Participants in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the operating room where they will undergo surgery without an indwelling catheter.
结局指标
主要结局
Time at readiness for discharge post-surgery
时间窗: Prior to discharge, average of 2 days postpartum
Time at readiness for discharge post-surgery will be collected via a form that will be distributed to the postpartum nursing team.
Time to ambulation
时间窗: Prior to discharge, an average of 2 days postpartum
Time to ambulation will be collected via a form that will be distributed to the postpartum nursing team.
Time to ambulation
时间窗: Prior to discharge, assessed up to 3 days postpartum
Time to ambulation will be collected via a form that will be distributed by the postpartum nursing team.
次要结局
- Operating time(During surgery)
- Incidence of bladder injury in surgery(During surgery)
- Incidence of urinary retention(Prior to discharge, an average of 2 days postpartum)
- Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum(first 4 weeks postpartum)
- Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)(Prior to discharge, an average of 2 days postpartum)
- Incidence of urinary retention(Prior to discharge, assessed up to 3 days postpartum)
- Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)(At discharge, assessed up to 3 days postpartum)
- Time to discharge(At discharge, assessed up to 3 days postpartum)