CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 134 enrolled
Drug / intervention
Stylettedevice
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.

Search/NCT02044458
NCT02044458N/ACompleted

A Randomized Control Trial of Foley Catheter Placement for Induction of Labor: Stylette Versus no Stylette

Wake Forest University Health Sciences·interventional·Posted Jan 24, 2014·Updated Oct 3, 2024

In Brief

A clinical study evaluating Stylette for Foley Catheterization and 2 related conditions. Completed, enrolled 134 participants across 1 site.

Detailed Summary

Study Design: Allocation: 2 arms Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Detailed Description The utilization of a Foley catheter for induction of labor is well established. There are two techniques readily used for placing a Foley catheter. The most common method is under direct visualization of the cervix during a sterile speculum examination and the other method is to place a catheter during a digital cervical examination. Studies have reported the use of a rigid stylette (a thin wire inserted into a catheter to maintain rigidity) to guide the insertion of the Foley catheter decreases failure rate. The Foley catheter plus rigid stylette technique seems to be an efficient and safe method for labor induction. However, to our knowledge there is no study that assesses the difference between the standard digital placement of a Foley catheter versus the digital placement of a Foley catheter with stylette.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 24, 2014
Enrollment StartApr 1, 2013
Primary CompletionMar 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.4 years ago

Interventions

Stylettedevice

use of stylette for successful insertion of foley catheter for induction of labor