Trials Today

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

Purpose

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Allocation will be determined based on a previously generated randomization scheme created by the NCI Clinical Trials Randomization Tool.
Primary Purpose: Prevention
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Intermittent catheterization		Procedure: Intermittent catheterization intermittent bladder catheterization every four hours, or shorter intervals if volume exceeds 500mL per expert recommendation
Active Comparator Continuous catheterization		Procedure: Continuous catheterization One catheter is placed in the bladder until pushing

Recruiting Locations

UPMC Magee-Womens Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15217

Contact:
Elena Lands, MD
7033465258
landsel@upmc.edu

More Details

NCT ID: NCT07125326
Status: Recruiting
Sponsor: University of Pittsburgh

Study Contact

Elena Lands, MD
7033465258
landsel@upmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.