Pregnancy, Abdominal
Conditions
Keywords
pregnancy, fetal monitoring, fetal oximetry, fetal heart rate, pulse oximetry, near infrared spectroscopy
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.
Interventions
DEVICERaydiant Oximetry Sensor System
Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women
Sponsors
CITRIS
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Greater than 36 weeks pregnant * Singleton fetus
Exclusion criteria
* Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed