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Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology

Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05853146
Enrollment
100
Registered
2023-05-10
Start date
2023-05-31
Completion date
2023-09-30
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetus Pulse Monitoring

Keywords

fetus, pulse, monitoring, pregnancy

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.

Interventions

DEVICEOxitone 1000M

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

Sponsors

Oxitone Medical Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy individuals between the age of 18-50

Exclusion criteria

* Clotting disorders, diabetes, currently taking psychotropic medications

Design outcomes

Primary

MeasureTime frameDescription
fetus pulsethrough study completion, an average of 1 yearfetus pulse calculated by a new algorithm

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026