NCT04362579

Advanced Multi-Modal Wearable Sensing for the Prediction of Pre-Term Labor

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Pregnancy Preterm

Interventions

Type	Name	Description
DEVICE	wearable vital signs sensor	vital signs monitoring during maternal non-stress testing or in the home setting

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-04-27
• Last updated: 2022-03-03

Locations

1 site across 1 country: United States