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Clinical Trial Summary

Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring


Clinical Trial Description

The primary objective of the Prentice study is to assess and validate EMG performance of the new home-use sensor with extended battery life in detecting continuous EHG in a range of uterine contraction intensities, frequencies, and durations compared to gold-standard FDA-cleared tocodynamometer (GE Corometrics 250cx) in non-stress testing for antepartum surveillance. An "at-home" study will validate the developed modifications to the wearable sensors system that provides a continuous electrohysterography (EHG) along with other additional physiological parameters (e.g. heart rate, heart rate variability, sleep quality, physical activity, and continuous blood pressure) for longitudinal monitoring in the home setting. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04362579
Study type Observational
Source Northwestern University
Contact
Status Completed
Phase
Start date January 1, 2021
Completion date December 1, 2021

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