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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02823873
• Other study ID #: 205588
• Status: Withdrawn
• Phase: N/A
• First received: June 16, 2016
• Last updated: July 20, 2016
• Start date: July 2016

Study information

• Verified date: July 2016
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Pulsewave oscillometric wrist cuff blood pressure monitor
Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No