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

Completed

• Conditions: Contraction
• Interventions: Device: The EUM300 (electrical uterine myography)

• Registration Number: NCT02993354
• Lead Sponsor: 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 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.

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 Timeline

• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-15
• Study Start: 2017-07-01
• Results First Submitted: 2021-07-08
• Primary Completion: 2021-09-21
• Study Completion: 2021-09-21
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Results First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Continuity in Readings of Contractions	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	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

Trial Locations

Locations (1)

Jack D. Weiler Hospital of Montefiore Medical Center; 🇺🇸 Bronx, New York, United States