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

NCT07125326 | Recruiting DMC

• 1 other identifier: STUDY24030142
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

catheterization; foley; catheter; urinary retention; voiding dysfunction; epidural; labor; bladder catheterization

Outcome Measures

Primary Outcomes (1)

• Postpartum urinary retention

  Urinary retention defined as overt inability to void at six hours after last bladder emptying postpartum or symptomatic incomplete emptying, or covert retention of \>150cc urine in the bladder after voiding Collecting number of participants who experience this

  Three days postpartum

Secondary Outcomes (7)

• Postpartum urinary tract infection

  One week postpartum

• Patient satisfaction

  Immediately postpartum

• Nurse satisfaction

  Immediately postpartum

• Voiding function at 2 weeks

  2 weeks postpartum

• Voiding function at 6 weeks

  6 weeks postpartum

Study Arms (2)

Intermittent catheterization

ACTIVE COMPARATOR

Procedure: Intermittent catheterization

Continuous catheterization

ACTIVE COMPARATOR

Procedure: Continuous catheterization

Interventions

Intermittent catheterization PROCEDURE

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

Intermittent catheterization

Continuous catheterization PROCEDURE

One catheter is placed in the bladder until pushing

Continuous catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15217, United States

RECRUITING

MeSH Terms

Conditions

Urinary Retention; Urinary Tract Infections; Disease

Interventions

Intermittent Urethral Catheterization

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urinary Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Anna Binstock, MD

  UPMC Magee-Womens Hospital

  STUDY CHAIR

Central Study Contacts

Elena Lands, MD

CONTACT

7033465258; landsel@upmc.edu

Anna Binstock, MD

CONTACT

3019288280; binstockab@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Medical Fellow

Model Details: Allocation will be determined based on a previously generated randomization scheme created by the NCI Clinical Trials Randomization Tool.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 15, 2025
• Study Start: December 9, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)