Stillbirth Risk Identification Using Multiparametric Ultrasound
NCT ID: NCT06930274
Last Updated: 2025-04-16
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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RECRUITING
282 participants
OBSERVATIONAL
2023-01-03
2025-09-30
Brief Summary
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Specifically the aim is to predict perinatal hypoxia using quantitative ultrasound from the placenta (QUS-P) between 35 and 37 weeks gestation.
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Detailed Description
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Primary outcome: Perinatal hypoxia
Background: Perinatal hypoxia is an inadequate supply to or utilization of oxygen by the fetus. It is typically diagnosed at delivery and can lead to serious medical complications, including encephalopathy, and ultimately stillbirth. Fetal hypoxia represents 23% of neonatal deaths worldwide.
Aim: To predict perinatal hypoxia using quantitative ultrasound from the placenta (QUS-P) between 35 weeks gestation and delivery.
Methods: Raw radio frequency data is collected during ultrasounds between 35 and 37 weeks gestation using ClariusTM (handheld ultrasound). All scans take place at BC Women's Hospital. QUS-P parameters are derived from the raw radio frequency data and analyzed using linear regression.
Impact: The ability to identify perinatal hypoxia as early as 35 weeks gestation will allow for additional monitoring as well as efforts to prepare for immediate intervention if necessary (e.g. c-section, resuscitation, neonatal cooling), prevent progression to encephalopathy, and ultimately stillbirth.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Age 19 years or older
3. Provision of informed consent
4. Planning to deliver at BC Women's Hospital
5. 38 weeks gestation or less
Exclusion Criteria
2. Not planning to deliver at BC Women's Hospital
3. Less than 19 years of age
4. Greater than 38 weeks gestation
19 Years
FEMALE
No
Sponsors
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Wellcome Trust
OTHER
University of British Columbia
OTHER
Responsible Party
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Robert Rohling
Professor
Principal Investigators
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Robert Rohling, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of British Columbia
Locations
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South Community Birth Program
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H22-02803
Identifier Type: -
Identifier Source: org_study_id
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