Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology

Oxitone Medical

Status: Not yet enrolling

Conditions: Fetus Pulse Monitoring

Treatments: Device: Oxitone 1000M

Study type: Observational

Funder types: Industry

Identifiers

NCT05853146

0262-22

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy individuals between the age of 18-50

Exclusion criteria

• Clotting disorders, diabetes, currently taking psychotropic medications

Trial design

100 participants in 1 patient group

pregnant women

Description:

Healthy women in their third trimester of pregnancy with one fetus

Treatment:

Device: Oxitone 1000M