Status:
COMPLETED
Advanced Multi-Modal Wearable Sensing for the Prediction of Pre-Term Labor
Lead Sponsor:
Northwestern University
Conditions:
Pregnancy Preterm
Eligibility:
FEMALE
18+ years
Brief Summary
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring
Detailed Description
The primary objective of the Prentice study is to assess and validate EMG performance of the new home-use sensor with extended battery life in detecting continuous EHG in a range of uterine contractio...
Eligibility Criteria
Inclusion
- Maternal age \>18 years old
- Pregnant mothers \>13 weeks (home study only)
- Pregnant mothers \>26 weeks undergoing nonstress testing or delivering
- Singleton pregnancy (inpatient or clinic visit patients only)
- History of preterm labor or premature birth, active smoker, chronic condition (ex: HTN or DM), or an interval of less than 6 months between the prior pregnancy
- Singleton pregnancy (home study only)
- No fetal abnormality or chromosomal abnormality
- Subjects willing and able to comply with requirements of the protocol
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04362579
Start Date
January 1 2021
End Date
December 1 2021
Last Update
March 3 2022
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611