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How the Method of Bladder Emptying After Epidural Placement in Labor Affects Postpartum Voiding

NCT ID: NCT07125326

Last Updated: 2025-11-12

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-08-31

Brief Summary

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At least ten percent of patients have postpartum urinary retention or difficulty urinating after birth, which can cause incontinence and other urinary problems long-term. After getting an epidural placed, patients should be numb in their pelvic region. This numbness makes it difficult to feel the need to urinate, so patients need a urinary catheter placed to empty the bladder. Some patients have one catheter placed throughout their labor and others have a catheter placed to empty the bladder then removed every few hours. The investigators are studying whether placing a catheter once or catheterizing multiple times affects the rate of postpartum urinary problems and infection.

Detailed Description

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This is a randomized controlled trial to assess the effect of bladder catheterization method during labor with epidural anesthesia on the rate of postpartum urinary retention.

Conditions

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Urinary Retention Urinary Tract Infection (Diagnosis) Postpartum Acute Urinary Retention Postpartum Care Voiding Dysfunction

Keywords

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catheterization foley catheter urinary retention voiding dysfunction epidural labor bladder catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Allocation will be determined based on a previously generated randomization scheme created by the NCI Clinical Trials Randomization Tool.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
While the patient, nursing team, and delivery providers will not be blinded to the catheterization method, the provider making the diagnosis of postpartum urinary retention will be blinded to the exposure group.

Study Groups

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Intermittent catheterization

Group Type ACTIVE_COMPARATOR

Intermittent catheterization

Intervention Type PROCEDURE

intermittent bladder catheterization every four hours, or shorter intervals if volume exceeds 500mL per expert recommendation

Continuous catheterization

Group Type ACTIVE_COMPARATOR

Continuous catheterization

Intervention Type PROCEDURE

One catheter is placed in the bladder until pushing

Interventions

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Intermittent catheterization

intermittent bladder catheterization every four hours, or shorter intervals if volume exceeds 500mL per expert recommendation

Intervention Type PROCEDURE

Continuous catheterization

One catheter is placed in the bladder until pushing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pregnant patients planning vaginal delivery presenting in labor or for induction of labor
* Age 18 years and older
* Live fetus
* Receive epidural anesthesia

Exclusion Criteria

* those under 18 years old
* those with stillbirth
* those with baseline overactive bladder symptoms, neurogenic bladder diagnoses, or otherwise using bladder catheterization during pregnancy

Patients will be excluded from UTI analyses if:

* they received antibiotics intrapartum
* had bacteriuria diagnosed by a clean catch specimen showing \>100,000 CFU/mL of a single bacterial species, regardless of symptoms
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Elena Lands

Graduate Medical Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Binstock, MD

Role: STUDY_CHAIR

UPMC Magee-Womens Hospital

Locations

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UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Elena Lands, MD

Role: CONTACT

Phone: 7033465258

Email: [email protected]

Anna Binstock, MD

Role: CONTACT

Phone: 3019288280

Email: [email protected]

Facility Contacts

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Elena Lands, MD

Role: primary

Other Identifiers

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STUDY24030142

Identifier Type: -

Identifier Source: org_study_id