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Search / Trial NCT06157203

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

Launched by PRETEL, INC · Nov 27, 2023

Trial Information

Current as of November 13, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Labor Status Monitor, which aims to help healthcare providers determine whether a pregnant person experiencing threatened labor is truly in labor or not. The device works by recording electrical signals from the uterus during contractions. The researchers want to set specific guidelines that will help them understand these signals better, which could lead to more accurate diagnoses for patients at risk of preterm birth. They will also gather feedback from participants and healthcare providers to improve comfort for patients and training for providers.

To be eligible for this study, participants need to be pregnant women who are between 24 and 37 weeks along in their pregnancy and experiencing signs of threatened labor. However, women with certain conditions, like a fetal anomaly or specific complications that require immediate delivery, cannot participate. If you join the trial, you can expect to wear the device during your labor assessment, and your feedback will contribute to improving the care for future patients in similar situations.

Gender

FEMALE

Eligibility 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

About Pretel, Inc

Pretel, Inc. is a forward-thinking clinical trial sponsor dedicated to advancing medical research and innovation. With a focus on developing novel therapeutics and medical interventions, Pretel, Inc. collaborates with leading healthcare professionals and institutions to design and execute rigorous clinical trials. The company is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring the safety and efficacy of its products for improved patient outcomes. By leveraging cutting-edge technology and a patient-centric approach, Pretel, Inc. strives to bring transformative solutions to the healthcare market.

Locations

Rochester, New York, United States

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Roger C Young, MD

Principal Investigator

PreTeL Chief Medical Officer

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported