Back to resultsFeasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAPP use
Sponsored by
About this trial
This is an interventional other trial for Postpartum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Any patient receiving CAPP during study period.
Exclusion Criteria:
- None (CAPP is only clinically indicated for obstetric hemorrhage post delivery.
Sites / Locations
- University of New Mexico
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAPP application
Arm Description
Patients in whom device is used
Outcomes
Primary Outcome Measures
Usage
Number of patients on whom CAPP is used
Secondary Outcome Measures
Side Effects
Any recorded complications
Full Information
NCT ID
NCT01497756
First Posted
December 20, 2011
Last Updated
February 25, 2020
Sponsor
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT01497756
Brief Title
Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)
Official Title
Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A group of midwives and obstetric nurses have been trained to use circumferential abdominal pelvic pressure (CAPP) to treat postpartum hemorrhage. As part of the training follow up any use of a CAPP device will be monitored to identify complications.
Detailed Description
Providers will be surveyed twice at 4 and 8 months using open ended methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAPP application
Arm Type
Experimental
Arm Description
Patients in whom device is used
Intervention Type
Device
Intervention Name(s)
CAPP use
Intervention Description
Any abdominal pelvic pressure
Primary Outcome Measure Information:
Title
Usage
Description
Number of patients on whom CAPP is used
Time Frame
Eight months
Secondary Outcome Measure Information:
Title
Side Effects
Description
Any recorded complications
Time Frame
Eight months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient receiving CAPP during study period.
Exclusion Criteria:
None (CAPP is only clinically indicated for obstetric hemorrhage post delivery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Hauswald, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
81435
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)
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