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

NCT ID: NCT07125326

Last Updated: 2025-11-12

Basic Information

• 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

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

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

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

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

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Elena Lands

Graduate Medical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Binstock, MD

Role: STUDY_CHAIR

UPMC Magee-Womens Hospital

Locations

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Elena Lands, MD

Role: CONTACT

landsel@upmc.edu

7033465258

Anna Binstock, MD

Role: CONTACT

binstockab@upmc.edu

3019288280

Facility Contacts

Elena Lands, MD

Role: primary

landsel@upmc.edu

7033465258

Other Identifiers

STUDY24030142

Identifier Type: -

Identifier Source: org_study_id