Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects

Not Applicable

Terminated

• Conditions: Pregnancy, Abdominal
• Interventions: Device: Raydiant Oximetry Sensor System

• Registration Number: NCT03013842
• Lead Sponsor: University of California, Davis

Brief Summary

Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human subjects, in order to obtain fetal heart rate.

We want to determine if this device can accurately measure a baby's oxygen level when placed on your abdomen.

Current technology to measure a baby's oxygen levels requires a probe to be inserted into the vagina.

Detailed Description

The study subject will have a brief trans-abdominal ultrasound examination.

3 trans-abdominal fetal oximetry probes will be tested for 5 minutes per probe. No probes will be placed into the vagina.

It is anticipated that 6 months will be required to recruit, consent and study 25 participants.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-05
• Study Start: 2016-12-12
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-09
• Primary Completion: 2017-08-02
• Study Completion: 2017-08-02
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

• Greater than 36 weeks pregnant
• Singleton fetus

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Exclusion Criteria

• Prisoners

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of Fetal Oximetry Probe	Raydiant Oximetry Sensor System	Administration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women

Primary Outcome Measures

Name	Time	Method
Fetal Photoplethysmogram	6 months	The primary outcome measure will be if a fetal photoplethysmogram is obtained in the time domain that correlates to the fetal heart rate.

Secondary Outcome Measures

Name	Time	Method
Fetal Heart Rate	6 months	The secondary endpoint will be if fetal heart rate can be obtained in the frequency domain that correlates to a fetal heart rate obtained by Doppler.

Trial Locations

Locations (1)

University of California, Davis Medical Center; 🇺🇸 Sacramento, California, United States