Clinical trial NCT03785795: Multichannel EMG Diagnosing True Preterm Labor
Official title: Optimizing and Validating an EMG-based Fetal Monitor to Identify True Preterm Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Preterm
Labor; Irregular
Preterm Labor
Keywords: Preterm labor detection
Labor detection
False labor
Lead sponsor: PreTeL, Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Rochester
First posted: 2018-12-24
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validating prediction of true/false labor status with delivery within 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Establishing the range and trend of synchronized sensor readings
timeFrame: 48 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: PreTeL, Inc
name: Roger C Young, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.