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Multichannel EMG Diagnosing True Preterm Labor

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03785795
Acronym
PTL
Enrollment
23
Registered
2018-12-24
Start date
2018-11-25
Completion date
2020-01-10
Last updated
2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor; Irregular, Pregnancy Preterm, Preterm Labor

Keywords

Preterm labor detection, Labor detection, False labor

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.

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.

Interventions

DEVICEUncertain 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

Sponsors

University of Rochester
CollaboratorOTHER
PreTeL, Inc
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Validating prediction of true/false labor status with delivery within 24 hours24 hoursThe test device predicts delivery. The prediction on each subject will be compared against the observed delivery time.

Secondary

MeasureTime frameDescription
Establishing the range and trend of synchronized sensor readings48 hoursThe fraction of EMG channels active during each contraction, and the running average of the fraction, will be correlated with time to delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026