Status:
TERMINATED
Trans-abdominal Fetal Pulse Oximetry: Signal Integrity
Lead Sponsor:
Raydiant Oximetry, Inc.
Conditions:
Fetal Distress
Eligibility:
FEMALE
18+ years
Brief Summary
This project is set up to advance and integrate the established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar ...
Detailed Description
The investigational device is a non-invasive fetal pulse oximeter that measures fetal arterial pulse signal using safe, noninvasive, transabdominal near-infrared spectroscopy. The optical sensor will ...
Eligibility Criteria
Inclusion
- Pregnant women with singleton pregnancies, vertex presentation
- Age ≥ 18 years
- Healthy women ≥ 28 weeks gestation undergoing either Non-Stress test (NST) or Biophysical profile (BPP) OR
- Healthy women ≥ 37 weeks in labor
- Vertex presentation
Exclusion
- Age \<18 years
- Multiple gestation ( twins, triplets)
- Presentation other than vertex
- \< 28 weeks of gestation
Key Trial Info
Start Date :
April 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04081623
Start Date
April 16 2019
End Date
June 8 2021
Last Update
August 11 2021
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111