Stillbirth Risk Identification Using Multiparametric Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Perinatal Hypoxia. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to identify a novel biomarker for stillbirth. Specifically the aim is to predict perinatal hypoxia using quantitative ultrasound from the placenta (QUS-P) between 35 and 37 weeks gestation.
Detailed description
Funding: Wellcome Leap, In Utero Program
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.
Primary outcome measures
- Presence of Perinatal Hypoxia at 35-37 weeks gestation [Time frame: 35-37 weeks gestation]
Eligibility criteria
Inclusion criteria
- Pregnant with singleton
- Age 19 years or older
- Provision of informed consent
- Planning to deliver at BC Women's Hospital
- 38 weeks gestation or less
Exclusion criteria
- Pregnant with multiples
- Not planning to deliver at BC Women's Hospital
- Less than 19 years of age
- Greater than 38 weeks gestation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- South Community Birth Program — Vancouver
Identifiers
NCT: NCT06930274 · H22-02803