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

NCT02993354 | Completed Results DMC FDA Device

• 1 other identifier: 2015-4881
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Pregnant women

Pregnant women with singleton pregnancy with gestational age greater than or equal to 24 weeks.

Device: The EUM300 (electrical uterine myography)

Interventions

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.

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Jack D. Weiler Hospital of Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (1)

• 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.

  PMID: 33852969 DERIVED

Results Point of Contact

• Title: Dr. Peter Bernstein
• Organization: Montefiore Medical Center

pbernste@montefiore.org

718-904-2767

Study Officials

• Peter Bernstein, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 15, 2016
• Study Start: July 1, 2017
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Locations

US (1)