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N/A Completed N=43 Device Feasibility

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

Source: ClinicalTrials.gov NCT02319174 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Accuracy of Blood Pressure Readings by Sphygmo — 114.5; 115.6; 65.7; 66.3 mmHg

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Accuracy of Blood Pressure Readings by Sphygmo
114.5; 115.6; 65.7; 66.3
PRIMARY
Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer.
67; 85; 98; 70; 89; 98

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02319174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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