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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Preterm
• Intervention / Treatment: Device: wearable vital signs sensor

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.

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

Description

• Maternal age >18 years old
• Pregnant mothers >13 weeks (home study only)
• Pregnant mothers >26 weeks undergoing nonstress testing or delivering
• Singleton pregnancy (inpatient or clinic visit patients only)
• History of preterm labor or premature birth, active smoker, chronic condition (ex: HTN or DM), or an interval of less than 6 months between the prior pregnancy
• Singleton pregnancy (home study only)
• No fetal abnormality or chromosomal abnormality
• Subjects willing and able to comply with requirements of the protocol

Exclusion Criteria

• Women who refuse to signed the informed consent form
• Maternal age under 18 years old
• Multiple pregnancy
• Known major fetal malformation or chromosomal abnormality
• Medical or obstetric problem that would preclude the use of abdominal electrodes
• Inability to consent to this study due to medical illness, diminished intellectual capacity, or language barrier
• Women using pacemakers

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects seen in hospital; 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.	Device: wearable vital signs sensor; vital signs monitoring during maternal non-stress testing or in the home setting
Home Study subjects; Subjects will be prescreened by an IRB approved staff and recruited from Prentice Women's Hospital's Department of Obstetrics and Gynecology.	Device: wearable vital signs sensor; vital signs monitoring during maternal non-stress testing or in the home setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device comparison to standard monitoring	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.	2 years

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Shuai Xu, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature
• Other Study ID Numbers: STU00210698

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No