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

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ClinicalTrials.gov Identifier: NCT01497756
Recruitment Status : Completed
First Posted : December 22, 2011
Results First Posted : September 17, 2012
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Mark Hauswald, University of New Mexico

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Device: CAPP use Not Applicable

Detailed Description:
Providers will be surveyed twice at 4 and 8 months using open ended methods.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)
Study Start Date : August 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: CAPP application
Patients in whom device is used
 Device: CAPP use
Any abdominal pelvic pressure


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


Secondary Outcome Measures :
  1. Side Effects [ Time Frame: Eight months ]
    Any recorded complications


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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
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United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 81435
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Mark Hauswald, MD University of New Mexico
More Information
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Responsible Party: Mark Hauswald, Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT01497756    
Other Study ID Numbers: 10-229
First Posted: December 22, 2011    Key Record Dates
Results First Posted: September 17, 2012
Last Update Posted: February 26, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
 Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage