Pregnant Women
Conditions
Brief summary
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring
Interventions
vital signs monitoring during maternal non-stress testing
Sponsors
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device comparison to standard monitoring | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative analyses of sensor output | 3 years | 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). |
Countries
United States
Outcome results
None listed