Validation of Pulsewave Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women
NCT ID: NCT02823873
Last Updated: 2016-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2016-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Normotensive
Normotensive pregnant and postpartum women will have blood pressure measurements administered with standard clinical equipment and the Pulsewave oscillometric wrist cuff blood pressure monitor.
Pulsewave oscillometric wrist cuff blood pressure monitor
Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology.
Hypertensive
Hypertensive pregnant and postpartum women will have blood pressure measurements administered with standard clinical equipment and the Pulsewave oscillometric wrist cuff blood pressure monitor.
Pulsewave oscillometric wrist cuff blood pressure monitor
Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology.
Interventions
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Pulsewave oscillometric wrist cuff blood pressure monitor
Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology.
Eligibility Criteria
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Inclusion Criteria
* Normotensive women - No diagnosis of hypertension
* Hypertensive women - Diagnosis of hypertensive disorder of pregnancy
Exclusion Criteria
* Women \< 18 years of age
* Non-english speakers
18 Years
FEMALE
No
Sponsors
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University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Jill Mhyre, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Countries
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Other Identifiers
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205588
Identifier Type: -
Identifier Source: org_study_id
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