CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 204 enrolled
Drug / intervention
Double-lumen balloon catheterdevice
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/NCT03086967
NCT03086967N/ACompleted
CompareCT.gov

Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours

Wake Forest University Health Sciences·interventional·Posted Mar 22, 2017·Updated Nov 30, 2022

In Brief

A clinical study evaluating Double-lumen balloon catheter for Induction of Labor Affected Fetus / Newborn. Completed, enrolled 204 participants across 1 site.

Detailed Summary

The Foley catheter is a safe, effective method for cervical ripening. Limited data exists to indicate ideal time of placement for optimal cervical ripening prior to induction. The proposed study is a randomized control trial to determine if shortening placement from 12 to 6 hours of foley catheter can decrease time from start of induction to delivery. The prediction is that shortening foley bulb placement will result in shorter induction times, increased patient satisfaction and decreased length of stay on labor and delivery with secondary decreased medical costs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInduction of Labor Affected Fetus / Newborn
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 22, 2017
Enrollment StartJun 1, 2013
Primary CompletionSep 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.3 years ago

Interventions

Double-lumen balloon catheterdevice

introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices