Advanced Multi-Modal Wearable Sensing for the Prediction of Pre-Term Labor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy Preterm
- Sponsor
- Northwestern University
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Device comparison to standard monitoring
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Shuai (Steve) Xu
Principal Investigator
Northwestern University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Device comparison to standard monitoring
Time Frame: 2 years
The primary outcome measure is concordance of FHR tracing assessments from Rogers sensor recordings with those obtained from the current standard of care electronic fetal monitoring systems.