Status:
COMPLETED
Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity
Lead Sponsor:
Raydiant Oximetry, Inc.
Conditions:
Fetal Hypoxia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The overall purpose of this study is to evaluate maternal-fetal tissue light scattering properties. The objectives of the study are: (i) integrate established mathematical principles of oxygen saturat...
Detailed Description
This is a prospective, observational, non-significant risk study. The study involves using non-invasive devices that measure fetal depth and tissue light scattering on the maternal abdomen. Ultrasound...
Eligibility Criteria
Inclusion
- Women with singleton, healthy pregnancy at gestational age ≥ 36 weeks
- Age \> 18 years
- Willing to come in for testing outside of routine business hours (including Saturdays)
Exclusion
- Age \<18
- Multiple gestation (twins, triplets)
- Presentation other than vertex or breech
- \< 36 weeks of gestation
Key Trial Info
Start Date :
April 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04876846
Start Date
April 24 2021
End Date
November 11 2025
Last Update
November 13 2025
Active Locations (1)
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1
Yaron Friedman, MD, Inc.
Walnut Creek, California, United States, 94598