Evaluation of CRB in PROM Patients
Primary Purpose
Premature Rupture of Fetal Membranes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRB
Pitocin
Sponsored by
About this trial
This is an interventional treatment trial for Premature Rupture of Fetal Membranes focused on measuring Premature Rupture of Membrane (Pregnancy), PROM, Cervical Ripening, Induced Labor
Eligibility 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
Sites / Locations
- Tucson Medical Center (TMC)
- University of South Florida
- Kosair Children's Hospital Maternal Fetal Medicine Specialists
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CRB plus Pitocin
Pitocin
Arm Description
Outcomes
Primary Outcome Measures
Time of Labor
Time, in minutes, from the start of labor induction through delivery
Incidence of Infection
number of patients with chorioamnionitis
Secondary Outcome Measures
Full Information
NCT ID
NCT01736852
First Posted
September 6, 2012
Last Updated
October 19, 2020
Sponsor
Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01736852
Brief Title
Evaluation of CRB in PROM Patients
Official Title
Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Rupture of Fetal Membranes
Keywords
Premature Rupture of Membrane (Pregnancy), PROM, Cervical Ripening, Induced Labor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRB plus Pitocin
Arm Type
Experimental
Arm Title
Pitocin
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
CRB
Intervention Description
Labor induction using the CRB
Intervention Type
Drug
Intervention Name(s)
Pitocin
Intervention Description
Labor induction using Pitocin
Primary Outcome Measure Information:
Title
Time of Labor
Description
Time, in minutes, from the start of labor induction through delivery
Time Frame
Start of labor induction through delivery, an expected average of 6 hours
Title
Incidence of Infection
Description
number of patients with chorioamnionitis
Time Frame
Through hospital discharge, an expected average of 3 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh Miller, MD
Organizational Affiliation
Watching Over Mothers and Babies (WOMB)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tucson Medical Center (TMC)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Kosair Children's Hospital Maternal Fetal Medicine Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
Evaluation of CRB in PROM Patients
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