CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Oxytocin +1 moredrug
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/NCT02465164
NCT02465164N/ACompleted

Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

Henry Ford Health System·interventional·Posted Jun 8, 2015·Updated May 22, 2023

In Brief

A clinical study evaluating Cook catheter and Oxytocin for Cervical Ripening. Completed, enrolled 26 participants.

Detailed Summary

The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in conjunction with low dose oxytocin is more effective at shortening labor induction times than the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by either Resident or Attending Physicians and left in place for 12 hours (protocol) in both groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will be used for the remainder of the induction per current hospital protocol. Time to delivery, mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be recorded.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 8, 2015
Enrollment StartJul 1, 2015
Primary CompletionJul 30, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.1 years ago

Interventions

Cook catheterdevice

Oxytocindrug