Wireless Wearable Maternal Fetal Sensors for Non-Stress Testing

Northwestern University1 site in 1 country91 target enrollmentApril 1, 2018

ConditionsPregnant Women

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pregnant Women
Sponsor: Northwestern University
Enrollment: 91
Locations: 1
Primary Endpoint: Device comparison to standard monitoring
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 1, 2018

End Date

September 6, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Northwestern University

Responsible Party

Principal Investigator

Shuai (Steve) Xu

Principal Investigator

Northwestern University

Eligibility Criteria

Inclusion Criteria

•Maternal age \>18 years old
•Pregnant mothers \>26 weeks undergoing nonstress testing or delivering
•Singleton pregnancy
•No fetal abnormality or chromosomal abnormality
•Subjects willing and able to comply with requirements of the protocol
•Nurses and clinicians who will be administering the non-stress test to the pregnant subject

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

Outcomes

Primary Outcomes

Device comparison to standard monitoring

Time Frame: 3 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.