Urinary Retention After Vaginal Delivery With Epidural Anesthesia.

Not Applicable

Recruiting

• Conditions: Urinary Retention
• Interventions: Device: Foley catheter; Device: Short term catheter; Drug: Epidural anesthesia

• Registration Number: NCT02865551
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-12
• Study Start: 2019-07-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-21
• Last Update Posted: 2023-01-25
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended catheterization	Foley catheter	Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor.
Extended catheterization	Epidural anesthesia	Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor.
Intermittent catheterization	Short term catheter	Participants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery.
Intermittent catheterization	Epidural anesthesia	Participants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery.

Primary Outcome Measures

Name	Time	Method
Rate of urinary retention after vaginal delivery with epidural anesthesia	Up to 3 days

Secondary Outcome Measures

Name	Time	Method
Rate of urinary tract infections	Up to 3 days

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel