Urinary Retention After Vaginal Delivery With Epidural Anesthesia.

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Recruiting

CT.gov ID

NCT02865551

Collaborator

(none)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators intend to compare the rate of urinary retention among female patients after vaginal delivery under epidural anesthesia, depending on bladder catheterization type, either by a foley catheter inserted adjacent to epidural anesthesia or intermittent catheterization applied every 4 hours during labor.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention	Device: Foley catheter Device: Short term catheter Drug: Epidural anesthesia	N/A

Detailed Description

An explanation about the study will be delivered to each participant and each participant will sign a confirmed consent. Patients will be randomized between 2 groups of treatment: 1. intermittent catheterization applied every 4 hours during labor. 2. foley catheter inserted adjacent to epidural anesthesia.

In patients with a foley catheter, the catheter will be removed soon after delivery. Participants will be followed by a clinician post labor. An abdominal US will be performed either 4 hours after delivery or after the participant urinates to check the bladder volume.

Patient information including demographic information, information regarding the patient's pregnancy and delivery will be collected from the patient's electronic record.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Rate of Urinary Retention in Women After Vaginal Delivery With Epidural Anesthesia Who Underwent Prolonged Catheterization Compared With Intermittent Catheterization During Labor.

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Extended catheterization Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor.	Device: Foley catheter Extended bladder catheterization after epidural anesthesia. Drug: Epidural anesthesia Performance of epidural anesthesia by a certified anesthesiologist.
Experimental: Intermittent catheterization Participants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery.	Device: Short term catheter Intermittent catheterization every 4 hours after epidural anesthesia. Drug: Epidural anesthesia Performance of epidural anesthesia by a certified anesthesiologist.

Arm

Intervention/Treatment

Experimental: Extended catheterization

Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor.

Device: Foley catheter

Extended bladder catheterization after epidural anesthesia.

Drug: Epidural anesthesia

Performance of epidural anesthesia by a certified anesthesiologist.

Experimental: Intermittent catheterization

Participants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery.

Device: Short term catheter

Intermittent catheterization every 4 hours after epidural anesthesia.

Drug: Epidural anesthesia

Performance of epidural anesthesia by a certified anesthesiologist.

Outcome Measures

Primary Outcome Measures

Rate of urinary retention after vaginal delivery with epidural anesthesia [Up to 3 days]

Secondary Outcome Measures

Rate of urinary tract infections [Up to 3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female patients in labor designated for vaginal delivery with epidural anesthesia.

Exclusion Criteria:

Patients with neurological problems including gestational diabetes.
Patients either designated for elective cesarean delivery or emergent cesarean delivery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam health care campus	Haifa		Israel

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator: Lior Lowenstein, MD, Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ROY LAUTERBACH MD, Dr. Roy Lauterbach, Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT02865551

Other Study ID Numbers:

0141-15-RMB

First Posted:

Aug 12, 2016

Last Update Posted:

Apr 20, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Retention

Anesthetics

Study Results

No Results Posted as of Apr 20, 2022