Hypertension Clinical Trial
Official title:
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.
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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