NCT00959920

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

Official Title:

Study of Obstetric Foley Therapy (SOFT Trial)

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Labor

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: PROCEDURE
    • Name: Indwelling catheter
    • Description: Indwelling bladder catheter will remain in place until time of delivery.
    • Arm Group Labels: Indwelling foley catheter
    • Type: PROCEDURE
    • Name: Intermittent straight catheterization
    • Description: intermittent straight catheterization will be performed on an as needed basis until time of delivery.
    • Arm Group Labels: Intermittent straight catheterization
Sponsor
  • Loyola University