At a glance
ClinicalIndex Comparison RecordN/ACompleted· 139 enrolled
Drug / intervention
Indwelling catheter +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study of Obstetric Foley Therapy (SOFT Trial)
In Brief
A clinical study evaluating Indwelling catheter and Intermittent straight catheterization for Labor. Completed, enrolled 139 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLabor
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedAug 2009
Primary CompletionDec 2009
TodayJul 2026
First PostedAug 17, 2009
Enrollment StartJul 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.9 years ago
Interventions
Indwelling catheterprocedure
Indwelling bladder catheter will remain in place until time of delivery.
Intermittent straight catheterizationprocedure
intermittent straight catheterization will be performed on an as needed basis until time of delivery.