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
9 participants
OBSERVATIONAL
2019-04-16
2021-06-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Clinic
This group is undergoing their scheduled visit for Non-Stress Test (NST) or Biophysical Profile (BPP)
Raydiant Oximetry Sensing System
The investigational device is used to record fetal pulse signals.
Labor and Delivery
This group is in active labor.
Raydiant Oximetry Sensing System
The investigational device is used to record fetal pulse signals.
Interventions
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Raydiant Oximetry Sensing System
The investigational device is used to record fetal pulse signals.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years
3. Healthy women ≥ 28 weeks gestation undergoing either Non-Stress test (NST) or Biophysical profile (BPP) OR
4. Healthy women ≥ 37 weeks in labor
5. Vertex presentation
Exclusion Criteria
2. Multiple gestation ( twins, triplets)
3. Presentation other than vertex
4. \< 28 weeks of gestation
18 Years
FEMALE
Yes
Sponsors
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Raydiant Oximetry, Inc.
INDUSTRY
Responsible Party
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Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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ROSS Gen 2
Identifier Type: -
Identifier Source: org_study_id
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