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NCT02993354: EUM

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

Completed Results posted Last updated 8 March 2024
What this trial tests

trial testing The EUM300 (electrical uterine myography) in Contraction in 48 participants. Completed in 21 September 2021.

Timeline
1 July 2017
Primary endpoint
21 September 2021
21 September 2021

Quick facts

Lead sponsorMontefiore Medical Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment48
Start date1 July 2017
Primary completion21 September 2021
Estimated completion21 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Montefiore Medical Center

Who can join

18 and older, female only, with Contraction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Continuity in Readings of Contractions Primary · 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.

GroupValue95% CI
EUM Device0± 0
Tocodynamometer0± 0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Montefiore Medical Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02993354.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing