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Clinical Trials/NCT05853146
NCT05853146
Not yet recruiting
Not Applicable

Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology

Oxitone Medical Ltd.0 sites100 target enrollmentMay 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fetus Pulse Monitoring
Sponsor
Oxitone Medical Ltd.
Enrollment
100
Primary Endpoint
fetus pulse
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

The purpose of the study is to examine the effectiveness and reliability of fetal heart rate monitoring by the Oxitone device.

Today, fetal monitoring is carried out with an external approach using a Doppler transducer placed on the mother's abdomen or with an internal approach only after water breaks and during active labor by connecting an electrode to the head of the fetus.

Oxyton's technology collects various physiological indicators and calculates an estimation of the fetal pulse. This monitoring method has a wide potential for use as part of pregnancy monitoring and perhaps even during childbirth.

Fetal heart rate will be measured in pregnant women in the third trimester of pregnancy with one fetus. The patients will wear the Oxitone device at the same time as Doppler monitoring in the hospital. An analysis of the data will be performed in comparison to the current accepted fetal monitor.

Registry
clinicaltrials.gov
Start Date
May 2023
End Date
September 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy individuals between the age of 18-50

Exclusion Criteria

  • Clotting disorders, diabetes, currently taking psychotropic medications

Outcomes

Primary Outcomes

fetus pulse

Time Frame: through study completion, an average of 1 year

fetus pulse calculated by a new algorithm

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