Optimizing the Management of Postpartum Urinary Retention
NCT ID: NCT04187365
Last Updated: 2022-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
70 participants
INTERVENTIONAL
2019-11-22
2022-02-27
Brief Summary
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Detailed Description
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Hypotheses
1. Longer duration of therapeutic catheterization will be associated with resolution of postpartum voiding dysfunction in women who sustain severe bladder distension injuries due to postpartum urinary retention.
Definition of resolution of postpartum voiding dysfunction:
A. A post void residual volume of less than half of initial instilled volume on the first retrograde voiding trial, AND B. No need for re-treatment for urinary retention within 1 week
2. The incidence of postpartum urinary retention (PUR) will vary by route of delivery, with operative vaginal delivery having the highest incidence.
3. Risk factors for PUR will be related to intrapartum and delivery conditions
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GROUP 1 (NonSevere PUR and women without PUR)
Women in GROUP 1 will be prospectively observed to characterize their clinical outcomes.
No interventions assigned to this group
GROUP 2 (Severe PUR)
Women in GROUP 2 will be a randomized to either 3 or 7 days of indwelling catheterization.
Duration of Indwelling Catheter
Foley catheter
Interventions
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Duration of Indwelling Catheter
Foley catheter
Eligibility Criteria
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Inclusion Criteria
2. Vaginal or cesarean delivery at term (37 weeks gestational age or later) of live-born infants.
3. English or Spanish speaking and reading.
Exclusion Criteria
2. Women under the age of 18.
3. Women who are currently pregnant (All women in the study will have already delivered).
4. Prisoners or detained individuals.
5. Women who chronically use a urinary catheter for another medical condition.
6. Women with a neurological disease with bladder manifestations (examples: Cerebrovascular accidents, Multiple sclerosis, Parkinson disease, cerebral palsy).
7. Women with preeclampsia requiring magnesium treatment for seizure prevention.
8. Women with prior PUR
9. Women on anticholinergic medications.
10. Women who are actively being treated for a UTI.
18 Years
FEMALE
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Sarah Collins
Assistant Professor, Department of Obstetrics & Gynecology
Principal Investigators
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Sarah Collins, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern Medicine
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00210382
Identifier Type: -
Identifier Source: org_study_id
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