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

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 study to validate the accuracy and clinical usefulness of the EUM device by simultaneously monitoring obese patients with current method of external tocodynamometry with the EUM device. Providers will be blinded to the results of the EUM device. Caregivers 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.

Study Overview

• Status: Completed
• Conditions: Contraction
• Intervention / Treatment: 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 (external tocodynamometry) among obese patients.

Objective:

Compare the interpretability of the contractions recorded using the EUM device vs. those obtained from external tocodynamometer among obese pregnant women.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Jack D. Weiler Hospital of Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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); This study involves monitoring one group of pregnant women for contractions simultaneously using two different devices to determine if one is superior: the usual tocodynamometer commonly used. Women are simultaneously monitored with both devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuity in Readings of Contractions	Continuity in readings of contractions, as measured in the number of minutes without a readable tracing in a sample tracing, between the novel EUM device and the external tocodynamometer (standard care) were assessed in pregnant preterm patients. An uninterpretable tracing was defined as any contraction, or any period of contractions, with unclear/uninterpretable baseline, peak onset/timing, height/peak, or duration of contraction.	within 4 hours of device application
Continuity in Readings of Fetal Heart Rate	Continuity in Fetal Heart rate readings, as measured by the number of minutes without a readable tracing in a sample tracing between the novel EUM/EMG device and the external tocodynamometer (standard care) will be assessed in pregnant preterm patients. An uninterpretable tracing is defined as any period of fetal heart rate tracing with unclear/uninterpretable baseline, variability, onset/timing, peak, frequency, or duration of accelerations/decelerations	within 4 hours of device application

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Peter Bernstein, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• Moni SS, Kirshenbaum R, Comfort L, Kuba K, Wolfe D, Xie X, Negassa A, Bernstein PS. Noninvasive monitoring of uterine electrical activity among patients with obesity: a new external monitoring device. Am J Obstet Gynecol MFM. 2021 Jul;3(4):100375. doi: 10.1016/j.ajogmf.2021.100375. Epub 2021 Apr 20.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): September 21, 2021
• Study Completion (Actual): September 21, 2021

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimated): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fetal Distress
• Other Study ID Numbers: 2015-4881

Drug and device information, study documents

• 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