Urinary Retention After Vaginal Delivery With Epidural Anesthesia.

Urinary Retention Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02865551
• Other study ID #: 0141-15-RMB
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Rambam Health Care Campus
• Contact: Roy Lauterbach, MD
• Phone: 972529432416
• Email: r_lauterbach[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Device:
• Foley catheter
Extended bladder catheterization after epidural anesthesia.
• Short term catheter
Intermittent catheterization every 4 hours after epidural anesthesia.

Drug:
• Epidural anesthesia
Performance of epidural anesthesia by a certified anesthesiologist.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of urinary retention after vaginal delivery with epidural anesthesia		Up to 3 days
Secondary	Rate of urinary tract infections		Up to 3 days