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 ]

The primary outcome measure will be if a fetal photoplethysmogram is obtained in the time domain that correlates to the fetal heart rate.


Original Primary Outcome: Photoplethysmogram [ Time Frame: 4 weeks ]

The primary outcome measure will be if a photoplethysmogram, volumetric measurement of an organ, is obtained from the probe that correlates to the fetal heart rate.


Current Secondary Outcome: 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.


Original Secondary Outcome: Fetal Heart Rate [ Time Frame: 4 weeks ]

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.


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