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

NCT06157203 | Unknown FDA Device

• 1 other identifier: STUDY00007700
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

PreTerm Labor; Threatened Preterm Labor; Preterm Birth

Outcome Measures

Primary Outcomes (5)

• Preterm birth

  BIrth prior to term

  24 hours

• Preterm birth

  BIrth prior to term

  48 hours

• Preterm birth

  BIrth prior to term

  7 days

• Preterm birth

  BIrth prior to term

  less than 37 weeks

• Preterm birth

  BIrth prior to term

  Term

Secondary Outcomes (1)

• Survey of subjects and clinical personnel

  12 months

Interventions

Uterine electromyography DEVICE

electromyographic and fetal electrocardiographic recordings will be obtained during threatened labor

Also known as: fetal electrocardiography

Eligibility Criteria

• Gender Eligibility Details: Subjects must be pregnant, hencemost or all will be pregnant women. Pregnant transgender males will be eligible for participation.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Low- or high-risk pregnancies that have achieved viability, anticipating a term delivery

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

Sponsors & Collaborators

• PreTeL, Inc: lead
• University of Rochester: collaborator
• Duke University: collaborator

Study Sites (2)

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Dume University Medical Center

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Roger C Young, MD

  PreTeL Chief Medical Officer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger C Young, MD

CONTACT

603 359 8870; ryoung@pretelhealth.com

Marc Finch

CONTACT

770 842 6806; mfinch@pretelhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: May 6, 2023
• Primary Completion: August 28, 2024
• Study Completion: October 28, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)