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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
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
Time of Labor
Time, in minutes, from the start of labor induction through delivery
Time frame: Start of labor induction through delivery, an expected average of 6 hours
Incidence of Infection
number of patients with chorioamnionitis
Time frame: Through hospital discharge, an expected average of 3 days
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