Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

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

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.

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01497756

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

Responsible Party: Mark Hauswald, Professor, University of New Mexico 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:
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage processed this record on October 27, 2016