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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The armpit will be measured as proximally as possible. The mid upper arm will be recorded by measuring at the halfway point between the acromion and the olecranon process. The distal upper arm measurement will be taken approximately 2 cm proximal to the antecubital crease. 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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Device: Pulsewave oscillometric wrist cuff blood pressure monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normotensive<br>Normotensive pregnant and postpartum women will have blood pressure measurements administered with standard clinical equipment and the Pulsewave oscillometric wrist cuff blood pressure monitor. | Device: Pulsewave oscillometric wrist cuff blood pressure monitor<br>* Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology.<br>|
| Hypertensive<br>Hypertensive pregnant and postpartum women will have blood pressure measurements administered with standard clinical equipment and the Pulsewave oscillometric wrist cuff blood pressure monitor. | Device: Pulsewave oscillometric wrist cuff blood pressure monitor<br>* Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of measurements by Pulsewave cuff that are within 5 mmHg of standard clinical measurements | Test measurement will be compared to standard measurements made at the same time. | Immediately after blood pressure measurement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Pregnant, Preeclampsia, Gestational Hypertension, Blood Pressure, Pregnant Women, Postpartum Women