Multichannel EMG Diagnosing True Preterm Labor
Condition: Pregnancy Preterm; Labor; Irregular; Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Observational

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.
    

Intervention name(s): Uncertain diagnosis of true labor
Intervention type(s): Device
Intervention description(s): 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
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.
      
Keywords: Preterm labor detection; Labor detection; False labor