N/A N=48

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

Contraction

Bottom Line

View on ClinicalTrials.gov: NCT02993354 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Continuity in Readings of Contractions — 0; 0 Number of minutes — p=0.75

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: The EUM300 (electrical uterine myography) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Montefiore Medical Center
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Continuity in Readings of Contractions	0; 0	0.75
PRIMARY Continuity in Readings of Fetal Heart Rate	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02993354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.