Monitoring labor status in pregnant individuals at risk of preterm birth
Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients
This study is testing a new device that helps pregnant people at risk of preterm birth figure out if they are really in labor or not, to make their care easier and more accurate.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 181 (estimated) |
| Sex | Female |
| Sponsor | PreTeL, Inc Industry-sponsored |
| Locations | 2 sites (Rochester, New York and 1 other locations) |
| Trial ID | NCT06157203 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on pregnant individuals experiencing threatened preterm labor. It utilizes a device that records electromyography signals to differentiate between true labor and threatened labor. The study aims to establish diagnostic thresholds for the Contraction Synchronization Index (CSI) and the False Labor Index (FSI) while also gathering feedback to improve patient comfort and provider training. Participants will be monitored for at least one hour to determine their labor status more efficiently than current methods.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals between 24 and 37 weeks gestation who are experiencing threatened labor.
Not a fit: Patients with fetal anomalies, non-vertex presentations, or those in fetal distress may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to quicker and more accurate diagnoses of labor status, potentially improving outcomes for preterm patients.
How similar studies have performed: While there are EMG-based fetal monitors, this specific approach for preterm patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pregnant persons more than 24 and less than 37 weeks gestation experiencing threatened labor Singleton pregnancy Exclusion Criteria: Fetal anomaly that removes fetal well-being from consideration during labor Non-vertex presentation Fetal distress of other indications for emergent delivery
Where this trial is running
Rochester, New York and 1 other locations
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- Dume University Medical Center — Durham, North Carolina, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Roger C Young, MD — PreTeL Chief Medical Officer
- Study coordinator: Roger C Young, MD
- Email: ryoung@pretelhealth.com
- Phone: 603 359 8870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.