CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 129 enrolled
Drug / intervention
Pitocin +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/NCT01736852
NCT01736852N/ACompleted
CompareCT.gov

Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients

Cook Group Incorporated·interventional·Posted Nov 29, 2012·Updated Oct 20, 2020

In Brief

A clinical study evaluating CRB and Pitocin for Premature Rupture of Fetal Membranes. Completed, enrolled 129 participants across 4 sites.

Detailed Summary

The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremature Rupture of Fetal Membranes
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 29, 2012
Enrollment StartNov 1, 2012
Primary CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 13.6 years ago

Interventions

CRBdevice

Labor induction using the CRB

Pitocindrug

Labor induction using Pitocin