Multichannel EMG Diagnosing True Preterm Labor

NCT03785795 | Completed FDA Device

• 1 other identifier: SBIR1.01
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

We have designed new electromyography sensors for measuring uterine activity. These sensors are directional - they preferentially report uterine muscle contractions at specific locations, called regions. By measuring the synchronization of the regions of the uterus during contractions we intend to non-invasively determine if any patient is in-labor or not-in-labor. Accurately diagnosing true preterm labor allows timely intervention to avoid preterm birth; Accurately diagnosing false preterm labor avoids needlessly treating patients who would not benefit.

Conditions

Pregnancy Preterm; Labor; Irregular; Preterm Labor

Keywords

Preterm labor detection; Labor detection; False labor

Outcome Measures

Primary Outcomes (1)

• Validating prediction of true/false labor status with delivery within 24 hours

  The test device predicts delivery. The prediction on each subject will be compared against the observed delivery time.

  24 hours

Secondary Outcomes (1)

• Establishing the range and trend of synchronized sensor readings

  48 hours

Study Arms (1)

Uncertain diagnosis of true labor

Patients who cannot be accurately classified as experiencing true labor or false labor based on standard clinical assessments.

Device: Uncertain diagnosis of true labor

Interventions

Uncertain diagnosis of true labor DEVICE

Multichannel EMG of uterine bioelectrical signals will be recorded using area sensors. The output of the synchronization calculations will be correlated with the time to delivery

Uncertain diagnosis of true labor

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Subjects must be pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with viable pregnancies who are experiencing uterine contractions will be studied. For each subject, her provider will not be certain if she is in true labor, or is experiencing false labor contractions. Other than experiencing contractions, subjects will have uncomplicated pregnancies. She will not have an indication for immediate delivery.

You may qualify if:

• Pregnant
• One living fetus
• Experiencing frequent uterine contractions

You may not qualify if:

• Cervical dilation \> 4 cm
• Ruptured membranes
• Maternal or fetal indications for immediate delivery

Sponsors & Collaborators

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

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Young RC. Mechanotransduction mechanisms for coordinating uterine contractions in human labor. Reproduction. 2016 Aug;152(2):R51-61. doi: 10.1530/REP-16-0156. Epub 2016 May 10.

  PMID: 27165050 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

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

Study Officials

• Roger C Young, MD

  PreTeL, Inc

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 24, 2018
• Study Start: November 25, 2018
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

US (1)