Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device

Study Overview
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Brief Summary
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The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is safe and effective in monitoring uterine contractions. The investigators propose to perform a series of studies to validate the accuracy and clinical usefulness of the EUM device by simultaneously monitoring patients with current methods (with either external or internal devices) as clinically indicated and with the EUM device. Providers will be blinded to the results of the EUM device. The investigators will continue care as per current guidelines using the information obtained from the current monitoring methods. Information obtained from the EUM devices will not be used to determine the clinical course of action.

Detailed Description
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Purpose: The investigators propose to perform a study to validate the accuracy and clinical usefulness of the EUM device by comparing it with simultaneous use of current methods (both external or internal devices) among obese patients and patients with normal body mass indexes (BMI). Objectives: Compare the contractions obtained using the EUM device vs. those obtained using the intrauterine pressure catheter vs. those obtained from external tocodynamometer among current obese patients (BMI greater than 30 kg/m2) and nonobese patients using simultaneously obtained, 30 minute tracings with regards to the frequency of contractions, the duration of contractions, maximum height of the contractions, the total Montevideo units recorded, the timing of the contractions, and the amount of discontinuous tracings from the devices. Compare the fetal heart rate tracing obtained via the EUM device vs. external fetal Doppler vs. fetal scalp electrode (simultaneously obtained, 30 minute tracings will be compared) among obese patients and nonobese patients with regards to the amount of discontinuous/unterinterpetable tracing, average fetal heart rate, baseline heart rate, the number accelerations, the number of decelerations, the timing of the accelerations, the timing of decelerations, the maximum fetal heart rate achieved during acceleration, the lowest fetal heart rate achieved during deceleration, and compare the degree of variability in the tracing. Compare tracings of productive vs. non-productive contractions in patients presenting to triage to rule out labor (30 minutes of simultaneously obtained tracings of external tocodynamometer and EUM device will be compared) with regards to the frequency of contractions, the duration of contractions, maximum height of contractions, the timing of the contractions and the amount of discontinuous tracings from both devices, as well as changes in cervical exam on the basis of body mass index.

Official Title
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Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device

Conditions
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Fetal Distress, Fetal Monitoring, Contraction

Intervention / Treatment
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* Device: The EUM300 (electrical uterine myography)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maternal age >18 years old Singleton pregnancy Gestational age of 24 completed weeks or greater based on the estimated due date as calculated from last menstrual period or early ultrasound Category I (reassuring) fetal heart rate tracing at time of enrollment Exclusion Criteria: Fetal anomaly or chromosome defect Allergy to silver Woman with implanted electronic device of any kind Irritated skin or open wound on the abdominal wall

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>Pregnant women with singleton pregnancy with gestational age greater than or equal to 24 weeks. | Device: The EUM300 (electrical uterine myography)<br>* External monitor intended for the evaluation of electrical signals originating in the uterus, thus providing a tool for measuring uterine activity as well as fetal heart rate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contractions | 1. Compare the contractions obtained using the EUM device vs. those obtained using the intrauterine pressure catheter vs. those obtained from external tocodynamometer among current obese patients (BMI greater than 30 kg/m2) and nonobese patients using simultaneously obtained, 30 minute tracings with regards to the frequency of contractions, the duration of contractions, maximum height of the contractions, the total Montevideo units recorded, the timing of the contractions, and the amount of discontinuous tracings from the devices. | 30 mins | 
| Fetal heart rate | 2. Compare the fetal heart rate tracing obtained via the EUM device vs. external fetal Doppler vs. fetal scalp electrode (simultaneously obtained, 30 minute tracings will be compared) among obese patients and nonobese patients with regards to the amount of discontinuous/unterinterpetable tracing, average fetal heart rate, baseline heart rate, the number accelerations, the number of decelerations, the timing of the accelerations, the timing of decelerations, the maximum fetal heart rate achieved during acceleration, the lowest fetal heart rate achieved during deceleration, and compare the degree of variability in the tracing. | 30 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Productive Contractions | 3. Compare tracings of productive vs. non-productive contractions in patients presenting to triage to rule out labor (30 minutes of simultaneously obtained tracings of external tocodynamometer and EUM device will be compared) with regards to the frequency of contractions, the duration of contractions, maximum height of contractions, the timing of the contractions and the amount of discontinuous tracings from both devices, as well as changes in cervical exam on the basis of body mass index. | 30 mins |