Evaluation of CRB in PROM Patients

Completed · Not applicable

Conditions studied: Premature Rupture of Fetal Membranes

In brief

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).

Key facts

Study ID

NCT01736852

Run by

Cook Group Incorporated

People needed

129

Starts

2012-11-01

Expected to finish

2018-12-31

Last updated by the study team

2020-10-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• PROM not in labor

You may not qualify if…

• Contraindication to vaginal delivery
• Contraindication to labor induction
• Abnormal fetal heart-rate patterns
• Maternal heart disease
• Severe maternal hypertension
• Pelvic structural abnormality

Where it is running

• 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

Full record on ClinicalTrials.gov

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