RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-06
Study Completion:2024-10-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06157203

Participation Criteria

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Roger C Young, MD
CONTACT
603 359 8870
ryoung@pretelhealth.com
Marc Finch
CONTACT
770 842 6806
mfinch@pretelhealth.com

Principal Investigator

Roger C Young, MD
PRINCIPAL_INVESTIGATOR
PreTeL Chief Medical Officer

Study Locations (Sites)

University of Rochester Medical Center
Rochester, New York, 14642
United States
Dume University Medical Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: PreTeL, Inc

  • Roger C Young, MD, PRINCIPAL_INVESTIGATOR, PreTeL Chief Medical Officer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-06
Study Completion Date2024-10-28

Study Record Updates

Study Start Date2023-05-06
Study Completion Date2024-10-28

Terms related to this study

Additional Relevant MeSH Terms

  • PreTerm Labor
  • Threatened Preterm Labor
  • Preterm Birth