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Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology

NCT05853146 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

  • Fetus Pulse Monitoring

Interventions

DEVICE

Oxitone 1000M

World's First FDA-cleared Wrist-Sensor Pulse Oximetry Monitor

Sponsors & Collaborators

  • Oxitone Medical Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2023-09-30
Completion
2023-09-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05853146 on ClinicalTrials.gov