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Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients
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).
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Tucson Medical Center (TMC)
Tucson, Arizona, United States
University of South Florida
Tampa, Florida, United States
Kosair Children's Hospital Maternal Fetal Medicine Specialists
Louisville, Kentucky, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Start Date
November 1, 2012
Primary Completion Date
December 31, 2018
Completion Date
December 31, 2018
Last Updated
October 20, 2020
129
ACTUAL participants
CRB
DEVICE
Pitocin
DRUG
Lead Sponsor
Cook Group Incorporated
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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