NCT04104165已完成不适用
Intermittent Versus Continous Catheterization for Treatment of Postpartum Urinary Retention.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Mean time for urinary retention resolution.
研究概览
简要总结
The aim of the study is to evaluate what is the most effective catheterization duration to resolve covert and overt postpartum urinary retention following vaginal delivery and caesarean delivery, with the highest patients' satisfaction.
详细描述
- Women who are unable to micturate for more than 6-8 hours following vaginal delivery or within six to eight hours following removal of an indwelling catheter after cesarean delivery (overt postpartum urinary retention), or women with postvoid residual bladder volume of at least 150 mL (covert postpartum urinary retention) will be randomized into 2 groups: one group will include women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours. If at any time, post voiding residual volume is less than 150cc (assessed by ultrasound or by catheterization), no additional catheterization is needed. The second group will include women which will have an indwelling catheter inserted for 24 hours. The catheter will be removed 24 hours following its insertion and post voiding residual volume will be assessed 6 hours following the catheter removal (by ultrasound or by catheterization). In cases of post voiding residual volume more than 150 cc or women are unable to micturate spontaneously, an indwelling catheter will be inserted for additional 24 hours.
- After 48 hours from postpartum urinary retention diagnosis, an indwelling catheter will be inserted for additional time that will be set at every center by its common protocol.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who deliver at one of the centers included in the study
- •Overt postpartum urinary retention which refers to the absence of spontaneous micturition within six to eight hours of vaginal delivery; or within six to eight hours following removal of an indwelling catheter after cesarean delivery
- •Covert postpartum urinary retention diagnosed by ultrasound or catheterization of more than 150cc
排除标准
- •Spontaneous micturition 6-8 hours following vaginal or cesarean delivery
- •postpartum urinary retention less than 150cc on ultrasound
- •Known urinary tract infection
结局指标
主要结局
Mean time for urinary retention resolution.
时间窗: Up to 10 days from diagnosis
Mean time for urinary retention resolution following the intervention.
次要结局
- Urinary tract infection rate(Up to 96 hours from diagnosis)
- Length of hospital stay(Up to 96 hours from diagnosis)
研究者
ROY LAUTERBACH MD
Principal investigator
Rambam Health Care Campus
研究点 (1)
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