Back to resultsUrinary Retention After Vaginal Delivery With Epidural Anesthesia.
Primary Purpose
Urinary Retention
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Foley catheter
Short term catheter
Epidural anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Retention
Eligibility Criteria
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.
Sites / Locations
- Rambam health care campusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Extended catheterization
Intermittent catheterization
Arm Description
Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor.
Participants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery.
Outcomes
Primary Outcome Measures
Rate of urinary retention after vaginal delivery with epidural anesthesia
Secondary Outcome Measures
Rate of urinary tract infections
Full Information
NCT ID
NCT02865551
First Posted
August 9, 2016
Last Updated
January 21, 2023
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT02865551
Brief Title
Urinary Retention After Vaginal Delivery With Epidural Anesthesia.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extended catheterization
Arm Type
Experimental
Arm Description
Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor.
Arm Title
Intermittent catheterization
Arm Type
Experimental
Arm Description
Participants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery.
Intervention Type
Device
Intervention Name(s)
Foley catheter
Intervention Description
Extended bladder catheterization after epidural anesthesia.
Intervention Type
Device
Intervention Name(s)
Short term catheter
Intervention Description
Intermittent catheterization every 4 hours after epidural anesthesia.
Intervention Type
Drug
Intervention Name(s)
Epidural anesthesia
Intervention Description
Performance of epidural anesthesia by a certified anesthesiologist.
Primary Outcome Measure Information:
Title
Rate of urinary retention after vaginal delivery with epidural anesthesia
Time Frame
Up to 3 days
Secondary Outcome Measure Information:
Title
Rate of urinary tract infections
Time Frame
Up to 3 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roy Lauterbach, MD
Phone
972529432416
Email
r_lauterbach@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lior Lowenstein, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam health care campus
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roy Lauterbach, MD
Phone
0529432416
Email
r_lauterbach@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Roy Lauterbach, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Urinary Retention After Vaginal Delivery With Epidural Anesthesia.
We'll reach out to this number within 24 hrs