- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02865551
Urinary Retention After Vaginal Delivery With Epidural Anesthesia.
The Rate of Urinary Retention in Women After Vaginal Delivery With Epidural Anesthesia Who Underwent Prolonged Catheterization Compared With Intermittent Catheterization During Labor.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Roy Lauterbach, MD
- Phone Number: 972529432416
- Email: r_lauterbach@rambam.health.gov.il
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- Rambam Health Care Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Extended catheterization
Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor.
|
Extended bladder catheterization after 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.
|
Performance of epidural anesthesia by a certified anesthesiologist.
Intermittent catheterization every 4 hours after epidural anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of urinary retention after vaginal delivery with epidural anesthesia
Time Frame: Up to 3 days
|
Up to 3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of urinary tract infections
Time Frame: Up to 3 days
|
Up to 3 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lior Lowenstein, MD, Rambam Health Care Campus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0141-15-RMB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Retention
-
Rambam Health Care CampusCompleted
-
TriHealth Inc.Completed
-
Lundbeck FoundationCompletedPostoperative Urinary RetentionDenmark
-
Mayo ClinicRecruitingPostoperative Urinary RetentionUnited States
-
Anand Rughani, MDMaineHealthCompletedPost-operative Urinary RetentionUnited States
-
University of RochesterTerminatedPost-Operative Urinary RetentionUnited States
-
Rigshospitalet, DenmarkLundbeck FoundationCompletedPostoperative Urinary Retention (POUR)Denmark
-
Wake Forest University Health SciencesTerminatedUrinary Retention PostoperativeUnited States
-
University of MichiganTerminatedPostoperative Urinary RetentionUnited States
-
Women and Infants Hospital of Rhode IslandAmerican Urogynecologic Society; American Association of Gynecologic LaparoscopistsActive, not recruitingVoiding Disorders | Urinary Retention PostoperativeUnited States
Clinical Trials on Foley catheter
-
Northwestern UniversityTerminated
-
The University of Texas Medical Branch, GalvestonActive, not recruitingLabor Induction | Early AmniotomyUnited States
-
Tyco Healthcare GroupCompletedUrinary Tract InfectionsUnited States
-
University of Alabama at BirminghamCompletedCervical Ripening | Labor InductionUnited States
-
HaEmek Medical Center, IsraelCompletedSingle Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable CervixInduction of LaborIsrael
-
The Cleveland ClinicWake Forest University Health SciencesUnknownPelvic Organ Prolapse | Surgery | Urinary Incontinence,StressUnited States
-
Rush University Medical CenterCompletedTotal Knee Arthroplasty | Postoperative Urinary Retention | Total Hip ArthroplastyUnited States
-
Princess Al-Johara Al-Ibrahim Cancer Research CenterCompletedProstatic ObstructionSaudi Arabia
-
Rambam Health Care CampusCompleted