Evaluation of CRB in PROM Patients

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cook; Cook Group Incorporated
• Treatments: Oxytocin

Criteria

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