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

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ClinicalTrials.gov Identifier: NCT02993354
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.)
First Posted : December 15, 2016
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Peter S. Bernstein, Montefiore Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Fetal Distress Fetal Monitoring Contraction Device: The EUM300 (electrical uterine myography)

Detailed Description:

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:

  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.
  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.
  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.

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 20, 2021
Estimated Study Completion Date : October 7, 2021

Group/Cohort Intervention/treatment
Pregnant women
Pregnant women with singleton pregnancy with gestational age greater than or equal to 24 weeks.
Device: The EUM300 (electrical uterine myography)
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.




Primary Outcome Measures :
  1. Contractions [ Time Frame: 30 mins ]
    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.

  2. Fetal heart rate [ Time Frame: 30 mins ]
    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.


Secondary Outcome Measures :
  1. Productive Contractions [ Time Frame: 30 mins ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women
Criteria

Inclusion Criteria:

  1. Maternal age >18 years old
  2. Singleton pregnancy
  3. Gestational age of 24 completed weeks or greater based on the estimated due date as calculated from last menstrual period or early ultrasound
  4. Category I (reassuring) fetal heart rate tracing at time of enrollment

Exclusion Criteria:

  1. Fetal anomaly or chromosome defect
  2. Allergy to silver
  3. Woman with implanted electronic device of any kind
  4. Irritated skin or open wound on the abdominal wall

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993354


Locations
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United States, New York
Jack D. Weiler Hospital of Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Peter Bernstein, MD Montefiore Medical Center
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Responsible Party: Peter S. Bernstein, MFM Fellowship Director, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02993354    
Other Study ID Numbers: 2015-4881
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fetal Distress
Signs and Symptoms