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

February 25, 2020 updated by: Mark Hauswald, University of New Mexico
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 81435
        • University of New Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Any patient receiving CAPP during study period.

Exclusion Criteria:

  • None (CAPP is only clinically indicated for obstetric hemorrhage post delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAPP application
Patients in whom device is used
Device: CAPP use
Any abdominal pelvic pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usage
Time Frame: Eight months
Number of patients on whom CAPP is used
Eight months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side Effects
Time Frame: Eight months
Any recorded complications
Eight months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: Mark Hauswald, MD, University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimate)

December 22, 2011

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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