Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-12-31

Brief Summary

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The goal of this study is to compare two clinically-relevant bladder drainage techniques. This is a randomized controlled trial with a single primary outcome of time to delivery. The results will inform clinical decisions about method of catheterization during labor.

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Detailed Description

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Urinary catheterization is a common practice during labor following placement of an epidural for pain control, as this form of anesthesia is known to inhibit normal bladder emptying. There is insufficient evidence to guide clinicians in selection of an indwelling catheter versus intermittent straight catheterization during the course of labor.

The goal of this randomized control trial is to compare two clinically-relevant bladder drainage techniques.

Conditions

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Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Indwelling foley catheter

Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.

Group Type ACTIVE_COMPARATOR

Indwelling catheter

Intervention Type PROCEDURE

Indwelling bladder catheter will remain in place until time of delivery.

Intermittent straight catheterization

Intermittent straight catheterization will be performed as needed during labor.

Group Type ACTIVE_COMPARATOR

Intermittent straight catheterization

Intervention Type PROCEDURE

intermittent straight catheterization will be performed on an as needed basis until time of delivery.

Interventions

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Indwelling catheter

Indwelling bladder catheter will remain in place until time of delivery.

Intervention Type PROCEDURE

Intermittent straight catheterization

intermittent straight catheterization will be performed on an as needed basis until time of delivery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women who present to either Loyola University Medical Center or Loyola at Gottlieb Hospital in active labor or for induction of labor with a singleton pregnancy and who are anticipated to undergo vaginal delivery during the current admission

Exclusion Criteria

* Women who are undergoing a scheduled cesarean delivery
* Women with a contraindication to either of the 2 study interventions
* Multi-fetal gestations
* Current or planned tocolysis
* Women who are on magnesium prophylaxis

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No