NCT05853146

Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Oxitone Medical Ltd. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	Oxitone 1000M	World's First FDA-cleared Wrist-Sensor Pulse Oximetry Monitor

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2023-05-10
• Last updated: 2023-05-10

Regulatory

• FDA-regulated device study