Validation of Pulsewave Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women



Status:Not yet recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:7/7/2016
Start Date:July 2016
Contact:Matthew W Bridges
Email:mbridges@uams.edu
Phone:501-686-6114

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Validation of Pulsewave Oscillometric Wrist Cuff Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women

The purpose of this study is to test the accuracy of the Pulsewave wrist blood pressure cuff
in pregnant and postpartum women who have either normal blood pressure or high blood
pressure.

The study will include a series of nine blood pressure measurements. The measurements will
alternate between a gold standard auscultatory blood pressure measurement and the Pulsewave
monitor.

A trained clinician will be used for gold standard measurements using an appropriately sized
cuff around the upper arm, a sphygmomanometer, and a stethoscope. Systolic blood pressure is
defined by the first Korotkoff sound; diastolic blood pressure is defined by the fifth
Korotkoff sound.

Measurements by the Pulsewave monitor will be performed using a proprietary oscillometric
wrist cuff automated by a computer tablet and software made by CloudDx Inc.

Women will be seated for 5 to 10 minutes before the first blood pressure measurement. During
this time, 4 circumference measurements will be taken of the arm and wrist.

1. The armpit will be measured as proximally as possible.

2. The mid upper arm will be recorded by measuring at the halfway point between the
acromion and the olecranon process.

3. The distal upper arm measurement will be taken approximately 2 cm proximal to the
antecubital crease.

4. The wrist will be measured approximately 2 cm proximal to the wrist flexion crease.

The first two blood pressure measurements will be used as a way to orient the subject to
each device and the methods so that they are comfortable with the cuff and the process. The
seven subsequent measurements will be used for analysis. There will be a 30 second to 60
second period between blood pressure measurements.

Inclusion Criteria:

- Pregnant or admitted to the postpartum unit

- Normotensive women - No diagnosis of hypertension

- Hypertensive women - Diagnosis of hypertensive disorder of pregnancy

Exclusion Criteria:

- Women in active labor

- Women < 18 years of age

- Non-english speakers
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Jill Mhyre, MD
Phone: 501-686-6114
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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mi
from
Little Rock, AR
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