Evaluation of CRB in PROM Patients

Cook Group

Status: Completed

Conditions: Premature Rupture of Fetal Membranes

Treatments: Drug: Pitocin; Device: CRB

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736852

09-014

Details and patient eligibility

About

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).

Enrollment: 129 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

CRB plus Pitocin

Experimental group

Treatment:

Device: CRB

Drug: Pitocin

Pitocin

Active Comparator group

Treatment:

Drug: Pitocin