Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology

NCT05853146 | Unknown FDA Device

• 1 other identifier: 0262-22
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fetus Pulse Monitoring

Keywords

fetus; pulse; monitoring; pregnancy

Outcome Measures

Primary Outcomes (1)

• fetus pulse

  fetus pulse calculated by a new algorithm

  through study completion, an average of 1 year

Study Arms (1)

pregnant women

Healthy women in their third trimester of pregnancy with one fetus

Device: Oxitone 1000M

Interventions

Oxitone 1000M DEVICE

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

pregnant women

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women in the third trimester of pregnancy with one fetus.

You may qualify if:

• Healthy individuals between the age of 18-50

You may not qualify if:

• Clotting disorders, diabetes, currently taking psychotropic medications

Sponsors & Collaborators

• Oxitone Medical Ltd.: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 10, 2023
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05