Evaluation of CRB in PROM Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01736852
Recruitment Status : Recruiting
First Posted : November 29, 2012
Last Update Posted : June 6, 2018
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Premature Rupture of Fetal Membranes Device: CRB Drug: Pitocin Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study to Compare the Cook Cervical Ripening Balloon Plus Pitocin to Pitocin Alone in PROM Patients
Study Start Date : November 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time of labor [ Time Frame: Start of labor induction through delivery, an expected average of 6 hours ]
  2. Incidence of infection [ Time Frame: Through hospital discharge, an expected average of 3 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01736852

Contact: Teresa Woolard, MHA 765-463-7537

United States, Arizona
Tucson Medical Center (TMC) Recruiting
Tucson, 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
Louisville, Kentucky, United States, 40202
United States, Texas
The University of Texas Health Science Center at Houston Completed
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cook Group Incorporated
Principal Investigator: Hugh Miller, MD Watching Over Mothers and Babies (WOMB)

Responsible Party: Cook Group Incorporated Identifier: NCT01736852     History of Changes
Other Study ID Numbers: 09-014
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2017

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

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