NCT02865551

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
2.9 years until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

4.3 years

First QC Date

August 9, 2016

Last Update Submit

January 21, 2023

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (1)

  • Rate of urinary retention after vaginal delivery with epidural anesthesia

    Up to 3 days

Secondary Outcomes (1)

  • Rate of urinary tract infections

    Up to 3 days

Study Arms (2)

Extended catheterization

EXPERIMENTAL

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

Device: Foley catheterDrug: Epidural anesthesia

Intermittent catheterization

EXPERIMENTAL

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

Device: Short term catheterDrug: Epidural anesthesia

Interventions

Foley catheterDEVICE

Extended bladder catheterization after epidural anesthesia.

Extended catheterization
Short term catheterDEVICE

Intermittent catheterization every 4 hours after epidural anesthesia.

Intermittent catheterization
Epidural anesthesiaDRUG

Performance of epidural anesthesia by a certified anesthesiologist.

Extended catheterizationIntermittent catheterization

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Urinary Retention

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Lior Lowenstein, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roy Lauterbach, MD

CONTACT

972529432416r_lauterbach@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Roy Lauterbach

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 12, 2016

Study Start

July 1, 2019

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)