Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
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|ClinicalTrials.gov Identifier: NCT03013842|
Recruitment Status : Terminated (Principal Investigator no longer at Site)
First Posted : January 9, 2017
Last Update Posted : January 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy, Abdominal||Device: Raydiant Oximetry Sensor System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects|
|Actual Study Start Date :||December 12, 2016|
|Actual Primary Completion Date :||August 2, 2017|
|Actual Study Completion Date :||August 2, 2017|
Experimental: Administration of Fetal Oximetry Probe
Administration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women
Device: Raydiant Oximetry Sensor System
Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women
Other Name: ROSS
- Fetal Photoplethysmogram [ Time Frame: 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.
- Fetal Heart Rate [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013842
|United States, California|
|University of California, Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Neil Ray, MD||916-734-5028|