Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients

Status unconfirmed

Conditions studied: PreTerm Labor, Threatened Preterm Labor, Preterm Birth

In brief

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.

Key facts

Study ID

NCT06157203

Run by

PreTeL, Inc

People needed

181

Starts

2023-05-06

Expected to finish

2024-10-28

Last updated by the study team

2023-12-05

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant persons more than 24 and less than 37 weeks gestation experiencing threatened labor Singleton pregnancy

You may not qualify if…

• Fetal anomaly that removes fetal well-being from consideration during labor Non-vertex presentation Fetal distress of other indications for emergent delivery

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• Dume University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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