We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of CRB in PROM Patients

This study is currently recruiting participants.
Verified June 2017 by Cook Group Incorporated
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736852
First Posted: November 29, 2012
Last Update Posted: July 2, 2017
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.
Information provided by (Responsible Party):
Cook Group Incorporated
  Purpose
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: 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

Resource links provided by NLM:


Further study details as provided by Cook Group Incorporated:

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

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01736852


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

Locations
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
Investigators
Principal Investigator: Hugh Miller, MD Watching Over Mothers and Babies (WOMB)
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01736852     History of Changes
Other Study ID Numbers: 09-014
First Submitted: September 6, 2012
First Posted: November 29, 2012
Last Update Posted: July 2, 2017
Last Verified: June 2017

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

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