Multichannel EMG Diagnosing True Preterm Labor
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies, Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 12/26/2018 |
| Start Date: | November 25, 2018 |
| End Date: | November 24, 2019 |
| Contact: | Roger C Young, MD |
| Email: | ryoung@pretelhealth.com |
| Phone: | 16033598870 |
Optimizing and Validating an EMG-based Fetal Monitor to Identify 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.
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.
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
We found this trial at
1
site
60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121
Phone: 585-275-7480
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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