Trial · Interventional

CompletedNot applicableResults postedRegistry data

Evaluation of CRB in PROM Patients

NCTNCT01736852Other id09-014

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 129 participants (actual)
Sponsor: Cook Group Incorporated · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Nov 2012
Primary completion: 31 Dec 2018
Completion: 31 Dec 2018
First posted: 29 Nov 2012 (estimated)
Last update posted: 20 Oct 2020
Conditions: Premature Rupture of Fetal Membranes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2012201420162018

N/A
Evaluation of CRB in PROM Patients
NCT01736852
Nov 2012 to 31 Dec 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

CRBDevice
PitocinDrug

Arms2

Experimental
CRB plus Pitocin
Active comparator
Pitocin

Primary outcomes2

Outcomes the sponsor listed as primary.

Time of Labor
Time frame · Start of labor induction through delivery, an expected average of 6 hours
Registry description
Time, in minutes, from the start of labor induction through delivery
Incidence of Infection
Time frame · Through hospital discharge, an expected average of 3 days
Registry description
number of patients with chorioamnionitis

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Start of labor induction through delivery, an expected average of 6 hours

Time of Labor

Group	Value (Minutes)	Spread
CRB Plus Pitocin	850.4	417.6
Pitocin	1016.6	595.7

Primary outcomeCount of participants· Through hospital discharge, an expected average of 3 days

Incidence of Infection

Group	Value (Participants)
CRB Plus Pitocin	7
Pitocin	6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
CRB Plus PitocinCRB: Labor induction using the CRB Pitocin: Labor induction using Pitocin	0 / 63	5 / 63	27 / 63
PitocinPitocin: Labor induction using Pitocin	0 / 61	4 / 61	21 / 61

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2026

Risk of Intra-Amniotic Infection After Cervical Ripening Balloon for Prelabor Rupture of Membranes: A Systematic Review and Meta-analysis.

Hessami et al. 2026Obstetrics and gynecology

PMID 42424638DOI 10.1097/aog.0000000000006362PUB-42424638

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * PROM not in labor Exclusion Criteria: * Contraindication to vaginal delivery * Contraindication to labor induction * Abnormal fetal heart-rate patterns * Maternal heart disease * Severe maternal hypertension * Pelvic structural abnormality

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