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

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.

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Key information

Conditions

Contraction

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Jack D. Weiler Hospital of Montefiore Medical Center

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The EUM300 (electrical uterine myography)

Device

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.

Primary outcomes

Continuity in Readings of Contractions

Time frame: within 4 hours of device application

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.
Continuity in Readings of Fetal Heart Rate

Time frame: within 4 hours of device application

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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Acronym: EUM

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Dec 15, 2016
Registry last updated: Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed