Status:
UNKNOWN
Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients
Lead Sponsor:
PreTeL, Inc
Collaborating Sponsors:
University of Rochester
Duke University
Conditions:
PreTerm Labor
Threatened Preterm Labor
Eligibility:
FEMALE
Brief Summary
This is an observational study of pregnant persons in threatened labor. The study device will record electromyography signals, then the signals will be examined to determine who is in true labor and w...
Detailed Description
This is a multicenter device optimization study, conducted as an observational cohort study. All subjects will self-present for evaluation of threatened preterm labor. Threatened labor is defined her...
Eligibility Criteria
Inclusion
- Pregnant persons more than 24 and less than 37 weeks gestation experiencing threatened labor Singleton pregnancy
Exclusion
- Fetal anomaly that removes fetal well-being from consideration during labor Non-vertex presentation Fetal distress of other indications for emergent delivery
Key Trial Info
Start Date :
May 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 28 2024
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT06157203
Start Date
May 6 2023
End Date
October 28 2024
Last Update
December 5 2023
Active Locations (2)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642
2
Dume University Medical Center
Durham, North Carolina, United States, 27710