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Completed

NCT Number: NCT00959920

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

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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Key information

Conditions

Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Health System

Maywood, Illinois, 60153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indwelling catheter

Procedure

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

Intermittent straight catheterization

Procedure

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

Primary outcomes

  1. Time to Delivery (by Any Route)

    Time frame: 1 day

    Time to delivery defined as IV placement to delivery of infant.

Secondary outcomes

  1. Difference in Cost Between the Two Interventions

    Time frame: End of study.

    Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

Study of Obstetric Foley Therapy (SOFT Trial)

Acronym: SOFT

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 17, 2009
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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