Multichannel EMG Diagnosing True Preterm Labor

Preterm Labor Clinical Trial

— PTL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03785795
• Other study ID #: SBIR1.01
• Status: Completed
• Start date: November 25, 2018
• Est. completion date: January 10, 2020

Study information

• Verified date: February 2020
• Source: PreTeL, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor; Irregular
• Obstetric Labor, Premature
• Pregnancy Preterm
• Premature Birth
• Preterm Labor

Intervention

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

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
PreTeL, Inc	University of Rochester

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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