Evaluation of CRB in PROM Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Cook
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 6, 2012
Last updated: March 14, 2016
Last verified: March 2016
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).

Condition Intervention
Premature Rupture of Fetal Membranes
Device: CRB
Drug: Pitocin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study to Compare the Cook Cervical Ripening Balloon Plus Pitocin to Pitocin Alone in PROM Patients

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • Time of labor [ Time Frame: Start of labor induction through delivery, an expected average of 6 hours ] [ Designated as safety issue: No ]
  • Incidence of infection [ Time Frame: Through hospital discharge, an expected average of 3 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CRB plus Pitocin Device: CRB
Labor induction using the CRB and Pitocin
Drug: Pitocin
Labor induction using Pitocin alone
Active Comparator: Pitocin Drug: Pitocin
Labor induction using Pitocin alone


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736852

Contact: Teresa Woolard, MHA 765-463-7537 teresa.woolard@CookMedical.com

United States, Arizona
Tucson Medical Center (TMC) Recruiting
Tuscon, Arizona, United States, 85712
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33606
United States, Kentucky
Kosair Children's Hospital Maternal Fetal Medicine Specialists Recruiting
Lousville, Kentucky, United States, 40202
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Principal Investigator: Hugh Miller, MD Watching Over Mothers and Babies (WOMB)
  More Information

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01736852     History of Changes
Other Study ID Numbers: 09-014 
Study First Received: September 6, 2012
Last Updated: March 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Premature Rupture of Membrane (Pregnancy)
Cervical Ripening
Induced Labor

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Pregnancy Complications
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 26, 2016