Multichannel EMG Diagnosing True Preterm Labor (PTL)

Optimizing and Validating an EMG-based Fetal Monitor to Identify True Preterm Labor

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.

Study Overview

• Status: Completed
• Conditions: Preterm Labor; Pregnancy Preterm; Labor; Irregular
• Intervention / Treatment: Device: Uncertain diagnosis of true labor

Detailed Description

The legacy device for assessing uterine contractions is the tocodynamometer (Toco). The Toco is plunger-driven device that measures the uterine shape change that occurs with a contraction. Toco only reports the timing of contractions, not the contraction strength, and cannot distinguish between false and true labor.

Our overarching goal is to validate our method of determining if a patient experiencing contractions is in true labor or false labor. We will accomplish this by applying new knowledge to an old technology - uterine EMG.

This trial is based on our advanced understanding of how the uterus generates coordinated contractions without a pacemaker or dedicated electrical conduction pathways - mechanotransduction and intrauterine pressure - but also uses bioelectrical signaling for local tissue recruitment.

The uterus emits bioelectrical signals with each contraction that can be detected by electromyography (EMG). To observe uterine bioelectrical signals, we created a novel EMG sensor, we call the "area sensor". This sensor is directional - capable of preferentially reporting muscle contractions from immediately below the sensor location.

In this clinical trial we use multiple area sensors placed on the maternal abdomen to directly observe how well the regional contractions are synchronized. Our hypothesis to be tested is that highly synchronized contractions predicts true labor, unsynchronized predicts false labor.

Patients with unclear labor status, or those in early labor will be studied. We will correlate the results of the synchronization analysis against the patient's progress over the ensuing 24 hours. These data will validate the ability to identify false and true labor using multichannel EMG and area sensors.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

• Pregnant
• One living fetus
• Experiencing frequent uterine contractions

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishing the range and trend of synchronized sensor readings	The fraction of EMG channels active during each contraction, and the running average of the fraction, will be correlated with time to delivery	48 hours

Collaborators and Investigators

• Sponsor: PreTeL, Inc
• Collaborators: University of Rochester
• Investigators: Principal Investigator: Roger C Young, MD, PreTeL, Inc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2018
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Preterm labor detection; Labor detection; False labor
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: SBIR1.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Specific patient EMG tracings may be shared based on unique characteristics of pregnancy subsets.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No