Multichannel EMG Diagnosing True Preterm Labor
Multichannel EMG Diagnosing 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.
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.
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