Clinical Trial: Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
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 Summary:
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.
Sponsor: University of California, Davis
Current Primary Outcome: Fetal Photoplethysmogram [ Time Frame: 6 months ]
Original Primary Outcome: Photoplethysmogram [ Time Frame: 4 weeks ]
Current Secondary Outcome: Fetal Heart Rate [ Time Frame: 6 months ]
Original Secondary Outcome: Fetal Heart Rate [ Time Frame: 4 weeks ]
Information By: University of California, Davis
Dates:
Date Received: December 5, 2016
Date Started: December 12, 2016
Date Completion: July 1, 2017
Last Updated: January 24, 2017
Last Verified: January 2017