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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension
• Intervention / Treatment: Device: Pulsewave oscillometric wrist cuff blood pressure monitor

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant or postpartum women recruited from the antepartum, labor & delivery, and postpartum units of the hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.	Device: Pulsewave oscillometric wrist cuff blood pressure monitor; Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Jill Mhyre, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Estimate): July 22, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Hypertension; Blood Pressure; Preeclampsia; Gestational Hypertension; Pregnant Women; Pregnant; Postpartum Women
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 205588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be de-identified. Data may be relevant to future studies regarding mobile health technology.