Recruiting

Labor Status Monitor

Sponsor:

PreTeL, Inc

Code:

NCT06157203

Conditions

PreTerm Labor

Threatened Preterm Labor

Preterm Birth

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Uterine electromyography

Study Details

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

Study ID

NCT06157203

Start date

May 6, 2023

Status verified date

Nov, 2023

Completion date

Oct 28, 2024

Anticipated

Primary completion date

Aug 28, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

181 participants

Anticipated

Interventions and Outcome Measures

Interventions

Uterine electromyography

electromyographic and fetal electrocardiographic recordings will be obtained during threatened labor

Primary outcome measure

  • Preterm birth [ Time Frame: 24 hours ]
  • Preterm birth [ Time Frame: 48 hours ]
  • Preterm birth [ Time Frame: 7 days ]
  • Preterm birth [ Time Frame: less than 37 weeks ]
  • Preterm birth [ Time Frame: Term ]

Central Contacts and Locations

Central contacts

Roger C Young, MD

603 359 8870ryoung@pretelhealth.com

Marc Finch

770 842 6806mfinch@pretelhealth.com

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Neil Seligman, MD

215-756-4897neil_seligman@urmc.rochester.edu

Ponnila Marinescu, MD

2072292040ponnila_marinescu@urmc.rochester.edu

More Information

Sponsor

PreTeL, Inc

Last update posted

Dec 5, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by PreTeL, Inc on 2023-12-05.