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 ContractionsPrimary· 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.
Group
Value
95% CI
EUM Device
0
± 0
Tocodynamometer
0
± 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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Sponsor: as reported to ClinicalTrials.gov by Montefiore Medical Center
Last refreshed: 8 March 2024
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.