Clinical trial NCT02823873: Validation of Pulsewave Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women
Official title: Validation of Pulsewave Oscillometric Wrist Cuff Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypertension
Keywords: Hypertension
Pregnant
Preeclampsia
Gestational Hypertension
Blood Pressure
Pregnant Women
Postpartum Women
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant or postpartum women recruited from the antepartum, labor \& delivery, and postpartum units of the hospital.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of measurements by Pulsewave cuff that are within 5 mmHg of standard clinical measurements
timeFrame: Immediately after blood pressure measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Jill Mhyre, MD
role: PRINCIPAL_INVESTIGATOR
References: