Evaluation of CRB in PROM Patients
Not Applicable
Completed
- Conditions
- Premature Rupture of Fetal Membranes
- Interventions
- Device: CRB
- Registration Number
- NCT01736852
- Lead Sponsor
- Cook Group Incorporated
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 129
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CRB plus Pitocin CRB - Pitocin Pitocin - CRB plus Pitocin Pitocin -
- Primary Outcome Measures
Name Time Method Time of Labor Start of labor induction through delivery, an expected average of 6 hours Time, in minutes, from the start of labor induction through delivery
Incidence of Infection Through hospital discharge, an expected average of 3 days number of patients with chorioamnionitis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
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