Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Pregnant Women

December 17, 2018 updated by: Rebecca Richards-Kortum, William Marsh Rice University

The purpose of the study is to help make a lower cost automatic blood pressure monitor device for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood pressure monitoring is limited or not available. The study will compare this low cost device to a commercially available system used for pre-eclamptic women in many United States hospitals that the investigators will be bringing to Malawi as a part of this study.

The team hopes to show that this lower cost blood pressure machine works well and can help women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to use.

70 pregnant women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at University of Texas Health Science Center Houston. Patient arm circumference will be measured with measurement tape.

They will be seated upright in a comfortable chair with arm at heart level and an arm blood pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer will be placed on the left arm.

The cuff will be inflated and then deflated until measurement concludes. Heart rate will be measured with tactile arterial palpation.The process will be repeated for a total of up to nine measurements, alternating between measurements with the automatic blood pressure monitor and the manual sphygmomanometer. There will be a waiting period of 45-60 seconds between each measurement.

The results of this study will help researchers understand the performance and usability of this device in Malawi and help decide if any design changes are needed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research team has developed an automatic blood pressure monitor to be used for the monitoring and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource settings where current monitoring is limited. This study aims to evaluate the accuracy of the device's blood pressure measurements in pregnant and pre-eclamptic women. This device must be evaluated with the above described population because blood pressure measurement devices are known to perform differently in pregnant and pre-eclamptic women than in normal healthy adults.

This study will take place at the University of Texas Health Science Center (UTHSC) where up to 70 subjects will be recruited to participate during their regularly scheduled antenatal care checkups.

  1. The Patient arm circumference will be measured with measurement tape.
  2. The Patient will be seated upright in a comfortable chair with arm at heart level.
  3. An arm blood pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer will be placed on the left arm of the patient over the brachial artery.
  4. Cuff will be inflated to ~200 mmHg and then deflated until measurement concludes.
  5. Heart rate will be measured with Tactile Arterial Palpation.
  6. Steps 3-4 will be repeated for a total of up to nine measurements, alternating between measurements with the automatic blood pressure monitor and the manual sphygmomanometer. There will be a waiting period of 45-60 seconds between each measurement.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women receiving antenatal care at the UT OB/GYN clinic.
  • Over the age of 18

Exclusion Criteria:

  • Women under the age of 18
  • Women unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sphygmo
All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device.
Device: Sphygmo
A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Blood Pressure Readings by Sphygmo
Time Frame: Blood pressure was measured an average of 9 times for each participant and the average of these measurements was recorded. Each measurement period lasted approximately 30-45 minutes
Mean difference of systolic and diastolic blood pressures between Sphygmo blood pressure measurements and measurements from the gold standard sphygmomanometer.
Blood pressure was measured an average of 9 times for each participant and the average of these measurements was recorded. Each measurement period lasted approximately 30-45 minutes
Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer.
Time Frame: Blood pressure was measured an average of 9 times for each participant during their single measurement period, and the average of those measurements was recorded. Each measurement period lasted approximately 30-45 minutes
The British Hypertension society defines a specific criteria for the accuracy of a sphygmomanometer. Devices are graded according to the cumulative percentage of readings that have an absolute difference between the more favorable observer's mercury sphygmomanometer readings and the test device of < 5 mmHg, < 10 mmHg, and < 15 mmHg. A letter grade of "A" requires that over 60%, 85%, and 95% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. A letter grade of "B" requires that over 50%, 75%, and 90% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. The test device achieved a grade of (A/A) with the validation data from this study.
Blood pressure was measured an average of 9 times for each participant during their single measurement period, and the average of those measurements was recorded. Each measurement period lasted approximately 30-45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Marsh Rice University

Collaborators

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Rebecca R Kortum, PhD, William Marsh Rice University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

November 4, 2016

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (Estimate)

December 18, 2014

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-082F-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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