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Urinary Retention After Vaginal Delivery With Epidural Anesthesia.

R

Rambam Health Care Campus

Status

Enrolling

Conditions

Urinary Retention

Treatments

Device: Short term catheter
Drug: Epidural anesthesia
Device: Foley catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT02865551
0141-15-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Extended catheterization
Experimental group
Description:
Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor.
Treatment:
Drug: Epidural anesthesia
Device: Foley catheter
Intermittent catheterization
Experimental group
Description:
Participants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery.
Treatment:
Device: Short term catheter
Drug: Epidural anesthesia

Trial contacts and locations

1

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Central trial contact

Roy Lauterbach, MD

Data sourced from clinicaltrials.gov

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