CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
The EUM300 (electrical uterine myography)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02993354
NCT02993354N/ACompleted

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

Montefiore Medical Center·observational·Posted Dec 15, 2016·Updated Mar 8, 2024

In Brief

An observational study evaluating The EUM300 (electrical uterine myography) for Contraction. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsContraction
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 15, 2016
Enrollment StartJul 1, 2017
Primary CompletionSep 21, 2021
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.5 years ago

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.