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

Completed

• Conditions: Pregnancy Preterm
• Interventions: Device: wearable vital signs sensor

• Registration Number: NCT04362579
• Lead Sponsor: Northwestern University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-27
• Study Start: 2021-01-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects seen in hospital	wearable vital signs sensor	Subjects will be recruited from Prentice Women's Hospital inpatient antepartum and labor and delivery services, and the outpatient Obstetrics and Gynecology practice, located within Galter tower with the assistance of staff.
Home Study subjects	wearable vital signs sensor	Subjects will be prescreened by an IRB approved staff and recruited from Prentice Women's Hospital's Department of Obstetrics and Gynecology.

Primary Outcome Measures

Name	Time	Method
Device comparison to standard monitoring	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States