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Principal Investigator no longer at Site
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| Name | Class |
|---|---|
| CITRIS | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of Fetal Oximetry Probe | Experimental | Administration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raydiant Oximetry Sensor System | Device | Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Photoplethysmogram | The primary outcome measure will be if a fetal photoplethysmogram is obtained in the time domain that correlates to the fetal heart rate. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Heart Rate | 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Ray, MD | 916-734-5028 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D011269 | Pregnancy, Abdominal |
| ID | Term |
|---|---|
| D011271 | Pregnancy, Ectopic |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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