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Evaluation of CRB in PROM Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01736852
First received: September 6, 2012
Last updated: July 14, 2014
Last verified: July 2014
  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 + Pitocin
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 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CRB Device: CRB + Pitocin
Labor induction using the CRB and Pitocin
Active Comparator: Control Drug: Pitocin
Labor induction using Pitocin alone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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

Contacts
Contact: Teresa Woolard, MHA 765-463-7537 twoolard@medinst.com

Locations
United States, Arizona
Tucson Medical Center (TMC) Recruiting
Tuscon, Arizona, United States, 85712
Contact: Nadine Jones    520-881-9662      
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Shelly W. Holmstrom, MD    813-259-8500    sholmstr@health.usf.edu   
United States, Texas
The University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Sean Blackwell, MD    713-500-6415    Sean.blackwell@uth.tmc.edu   
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Hugh Miller, MD Watching Over Mothers and Babies (WOMB)
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01736852     History of Changes
Other Study ID Numbers: 09-014
Study First Received: September 6, 2012
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014