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

NCT02823873 | Withdrawn

• 1 other identifier: 205588
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; Pregnant; Preeclampsia; Gestational Hypertension; Blood Pressure; Pregnant Women; Postpartum Women

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Pulsewave oscillometric wrist cuff blood pressure monitor DEVICE

Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology.

Hypertensive; Normotensive

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Pregnant or admitted to the postpartum unit
• Normotensive women - No diagnosis of hypertension
• Hypertensive women - Diagnosis of hypertensive disorder of pregnancy

You may not qualify if:

• Women in active labor
• Women \< 18 years of age
• Non-english speakers

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jill Mhyre, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Last Updated: July 22, 2016

Record last verified: 2016-07

Locations

US (1)