Maternal Non-Stress Testing
Completed
- Conditions
- Pregnant Women
- Registration Number
- NCT04343482
- Lead Sponsor
- Northwestern University
- Brief Summary
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 91
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Northwestern Medicine Prentice Women's Hospital
🇺🇸Chicago, Illinois, United States