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

Northwestern University

Status: Completed

Conditions: Pregnancy Preterm

Treatments: Device: wearable vital signs sensor

Study type: Observational

Funder types: Other

Identifiers

NCT04362579

STU00210698

Details and patient eligibility

About

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

Full 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.

Enrollment: 91 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

91 participants in 2 patient groups

Subjects seen in hospital

Description:

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.

Treatment:

Device: wearable vital signs sensor

Home Study subjects

Description:

Subjects will be prescreened by an IRB approved staff and recruited from Prentice Women's Hospital's Department of Obstetrics and Gynecology.

Treatment:

Device: wearable vital signs sensor