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

NCT02319174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-12-19

Study results available
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Summary

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.

Conditions

  • Pre Eclampsia

Interventions

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

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • William Marsh Rice University

    lead OTHER

Principal Investigators

  • Rebecca R Kortum, PhD · William Marsh Rice University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-06-30
Completion
2016-11-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02319174 on ClinicalTrials.gov