Multichannel EMG Diagnosing True Preterm Labor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-25

Study Completion Date

2020-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Two Methods of Contractions Monitoring for Clinical Decision Making Regarding Treatment Among Pregnant Women With Preterm Contractions.

NCT02875418

Fetal Heartbeat Tracings

UNKNOWN PHASE3

Cervix Monitor for Elasticity and Length Measurements

NCT03199079

Preterm Birth

COMPLETED

Electrical Inhibition of Human Preterm Contractions

NCT02983240

Preterm Labor PreTerm Birth Preterm Labor With Delivery Nos

SUSPENDED NA

Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians

NCT01282723

Pregnancy - Labor Monitoring

COMPLETED

Cervical Softening and the Prediction of Preterm Birth

NCT05477381

Preterm Birth Threatened Preterm Labor Premature Birth +4 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Preterm Labor; Irregular Preterm Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Uncertain diagnosis of true labor

Patients who cannot be accurately classified as experiencing true labor or false labor based on standard clinical assessments.

Uncertain diagnosis of true labor

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Uncertain 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

Intervention Type DEVICE