Maternal Non-Stress Testing

N/ACompletedNCT04343482

Northwestern University91 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pregnant Women

Interventions

wearable vital signs sensorDEVICE

vital signs monitoring during maternal non-stress testing

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 years

Secondary Outcomes

Qualitative analyses of sensor output

Qualitative analyses of FHR, MHR, BP, pulse oximetry, and UC data capture from the sensors will be performed for the purpose of optimizing signal-to-noise filtering of raw data collected during the study. Any adverse events will be recorded such as skin irritation (expected to be negligible).

Time frame: 3 years

Data from ClinicalTrials.gov

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