NCT04104165CompletedNot Applicable
Intermittent Versus Continous Catheterization for Treatment of Postpartum Urinary Retention.
Rambam Health Care Campus1 site in 1 country146 target enrollmentStarted: January 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Mean time for urinary retention resolution.
Study Overview
Brief Summary
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.
Detailed Description
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Spontaneous micturition 6-8 hours following vaginal or cesarean delivery
- •postpartum urinary retention less than 150cc on ultrasound
- •Known urinary tract infection
Outcomes
Primary Outcomes
Mean time for urinary retention resolution.
Time Frame: Up to 10 days from diagnosis
Mean time for urinary retention resolution following the intervention.
Secondary Outcomes
- Urinary tract infection rate(Up to 96 hours from diagnosis)
- Length of hospital stay(Up to 96 hours from diagnosis)
Investigators
ROY LAUTERBACH MD
Principal investigator
Rambam Health Care Campus
Study Sites (1)
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