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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
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
September 6, 2012
Last Updated
October 19, 2020
Sponsor
Cook Group Incorporated
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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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