Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology
- Conditions
- Fetus Pulse Monitoring
- Interventions
- Device: Oxitone 1000M
- Registration Number
- NCT05853146
- Lead Sponsor
- Oxitone Medical Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- Healthy individuals between the age of 18-50
- Clotting disorders, diabetes, currently taking psychotropic medications
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description pregnant women Oxitone 1000M Healthy women in their third trimester of pregnancy with one fetus
- Primary Outcome Measures
Name Time Method fetus pulse through study completion, an average of 1 year fetus pulse calculated by a new algorithm
- Secondary Outcome Measures
Name Time Method