Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
NCT ID: NCT03013842
Last Updated: 2018-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2016-12-12
2017-08-02
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Administration of Fetal Oximetry Probe
Administration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women
Raydiant Oximetry Sensor System
Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women
Interventions
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Raydiant Oximetry Sensor System
Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton fetus
Exclusion Criteria
18 Years
40 Years
FEMALE
No
Sponsors
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CITRIS
UNKNOWN
University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Neil Ray, MD
Role: PRINCIPAL_INVESTIGATOR
916-734-5028
Locations
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University of California, Davis Medical Center
Sacramento, California, United States
Countries
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Other Identifiers
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828902
Identifier Type: -
Identifier Source: org_study_id