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

NCT ID: NCT04362579

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 91 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-12-01

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.

Conditions

Pregnancy Preterm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

wearable vital signs sensor

Intervention Type: DEVICE

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.

wearable vital signs sensor

Intervention Type: DEVICE

vital signs monitoring during maternal non-stress testing or in the home setting

Interventions

wearable vital signs sensor

vital signs monitoring during maternal non-stress testing or in the home setting

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Shuai (Steve) Xu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuai Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00210698

Identifier Type: -

Identifier Source: org_study_id