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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497756
First Posted: December 22, 2011
Last Update Posted: September 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark Hauswald, University of New Mexico
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)

Resource links provided by NLM:


Further study details as provided by Mark Hauswald, University of New Mexico:

Primary Outcome Measures:
  • Usage [ Time Frame: Eight months ]
    Number of patients on whom CAPP is used


Secondary Outcome Measures:
  • Side Effects [ Time Frame: Eight months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mark Hauswald, Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT01497756     History of Changes
Other Study ID Numbers: 10-229
First Submitted: December 20, 2011
First Posted: December 22, 2011
Results First Submitted: July 2, 2012
Results First Posted: September 17, 2012
Last Update Posted: September 17, 2012
Last Verified: August 2012

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