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Evaluation of CRB in PROM Patients

This study is currently recruiting participants.
Verified March 2013 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01736852
First received: September 6, 2012
Last updated: March 16, 2013
Last verified: March 2013
History of Changes
  Purpose

The CRB study is a non-significant risk clinical trial to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) in the induction of labor in 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:

Drug Information available for: Oxytocin
U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Incidence of infection [ Time Frame: Through hospital discharge, an expected average of 3 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 170
Study Start Date: November 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736852

Contacts
Contact: Victoria Martin, PhD 765-463-7537 vmartin@medinst.com

Locations
United States, Arizona
Tucson Medical Center (TMC) Recruiting
Tuscon, Arizona, United States, 85712
Contact: Diane Mercer     520-881-9662        
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: March 16, 2013
Health Authority: United States: Institutional Review Board

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
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013