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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.
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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsewave oscillometric wrist cuff blood pressure monitor | Device | Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant or postpartum women recruited from the antepartum, labor & delivery, and postpartum units of the hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Jill Mhyre, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
Data will be de-identified. Data may be relevant to future studies regarding mobile health technology.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |