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

Contraction Clinical Trial

— EUM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993354
• Other study ID #: 2015-4881
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: September 21, 2021

Study information

• Verified date: March 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 21, 2021
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraction

Intervention

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.

Locations

Country	Name	City	State
United States	Jack D. Weiler Hospital of Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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