Evaluation of CRB in PROM Patients
Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients
1 other identifier
interventional
129
1 country
4
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedResults Posted
Study results publicly available
October 20, 2020
CompletedOctober 20, 2020
October 1, 2020
6.2 years
September 6, 2012
September 1, 2020
October 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time of Labor
Time, in minutes, from the start of labor induction through delivery
Start of labor induction through delivery, an expected average of 6 hours
Incidence of Infection
number of patients with chorioamnionitis
Through hospital discharge, an expected average of 3 days
Study Arms (2)
CRB plus Pitocin
EXPERIMENTALPitocin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- PROM not in labor
You may not qualify if:
- Contraindication to vaginal delivery
- Contraindication to labor induction
- Abnormal fetal heart-rate patterns
- Maternal heart disease
- Severe maternal hypertension
- Pelvic structural abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Tucson Medical Center (TMC)
Tucson, Arizona, 85712, United States
University of South Florida
Tampa, Florida, 33606, United States
Kosair Children's Hospital Maternal Fetal Medicine Specialists
Louisville, Kentucky, 40202, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alan Saunders,MS, RAC; Manager, Biostatistics
- Organization
- Cook Research Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Hugh Miller, MD
Watching Over Mothers and Babies (WOMB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2012
First Posted
November 29, 2012
Study Start
November 1, 2012
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
October 20, 2020
Results First Posted
October 20, 2020
Record last verified: 2020-10