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 who is in threatened labor. The two goals are: * To establish the thresholds for the Contraction Synchronization Index (CSI) and the False Labor Index (FSI) to be used by the Labor Status Monitor to diagnose in-Labor or Not-in-Labor for preterm patients with threatened labor * To obtain feedback from subjects and providers to assist with enhancing patient comfort and provider training.
PreTerm Labor, Threatened Preterm Labor, Preterm Birth
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 who is in threatened labor. The two goals are: * To establish the thresholds for the Contraction Synchronization Index (CSI) and the False Labor Index (FSI) to be used by the Labor Status Monitor to diagnose in-Labor or Not-in-Labor for preterm patients with threatened labor * To obtain feedback from subjects and providers to assist with enhancing patient comfort and provider training.
Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients
-
University of Rochester Medical Center, Rochester, New York, United States, 14642
Dume University Medical Center, Durham, North Carolina, United States, 27710
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
to
FEMALE
Yes
PreTeL, Inc,
Roger C Young, MD, PRINCIPAL_INVESTIGATOR, PreTeL Chief Medical Officer
2024-10-28