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

NCT04362579 | Completed

• 1 other identifier: STU00210698
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Preterm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

wearable vital signs sensor DEVICE

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

Home Study subjects; Subjects seen in hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Study Officials

• Shuai Xu, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 27, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

US (1)