NCT01497756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
5 months until next milestone

Results Posted

Study results publicly available

September 17, 2012

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

December 20, 2011

Results QC Date

July 2, 2012

Last Update Submit

February 25, 2020

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Usage

    Number of patients on whom CAPP is used

    Eight months

Secondary Outcomes (1)

  • Side Effects

    Eight months

Study Arms (1)

CAPP application

EXPERIMENTAL

Patients in whom device is used

Device: CAPP use

Interventions

CAPP useDEVICE

Any abdominal pelvic pressure

CAPP application

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient receiving CAPP during study period.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 81435, United States

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Mark Hauswald MD
Organization
uNewMexico
markhauswald@gmail.com
505-269-6699

Study Officials

  • Mark Hauswald, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 22, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

February 26, 2020

Results First Posted

September 17, 2012

Record last verified: 2020-02

Locations

US(1)