Evaluation of CRB in PROM Patients

Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients

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).

Study Overview

• Status: Completed
• Conditions: Premature Rupture of Fetal Membranes
• Intervention / Treatment: Device: CRB; Drug: Pitocin

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center (TMC)
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kosair Children's Hospital Maternal Fetal Medicine Specialists
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRB plus Pitocin	Device: CRB; Labor induction using the CRB; Drug: Pitocin; Labor induction using Pitocin
Active Comparator: Pitocin	Drug: Pitocin; Labor induction using Pitocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Labor	Time, in minutes, from the start of labor induction through delivery	Start of labor induction through delivery, an expected average of 6 hours
Incidence of Infection	number of patients with chorioamnionitis	Through hospital discharge, an expected average of 3 days

Collaborators and Investigators

• Sponsor: Cook Group Incorporated
• Investigators: Principal Investigator: Hugh Miller, MD, Watching Over Mothers and Babies (WOMB)

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: September 6, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: PROM; Cervical Ripening; Premature Rupture of Membrane (Pregnancy); Induced Labor
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Fetal Membranes, Premature Rupture; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 09-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.