Text Size

Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Hauswald, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01497756
First received: December 20, 2011
Last updated: August 17, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
 Device: CAPP use

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Usage [ Time Frame: Eight months ] [ Designated as safety issue: No ]
    Number of patients on whom CAPP is used


Secondary Outcome Measures:
  • Side Effects [ Time Frame: Eight months ] [ Designated as safety issue: Yes ]
    Any recorded complications


Enrollment: 10
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAPP application
Patients in whom device is used
 Device: CAPP use
Any abdominal pelvic pressure

Detailed Description:

Providers will be surveyed twice at 4 and 8 months using open ended methods.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient receiving CAPP during study period.

Exclusion Criteria:

  • None (CAPP is only clinically indicated for obstetric hemorrhage post delivery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497756

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 81435
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Mark Hauswald, MD University of New Mexico
  More Information

No publications provided

Responsible Party: Mark Hauswald, Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT01497756     History of Changes
Other Study ID Numbers: 10-229
Study First Received: December 20, 2011
Results First Received: July 2, 2012
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
 Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage

ClinicalTrials.gov processed this record on June 17, 2013