NCT06930274

Stillbirth Risk Identification Using Multiparametric Ultrasound

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 282 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Perinatal Hypoxia

Timeline

• Start date: 2023-01-03
• Primary completion: 2025-07-30
• Completion: 2025-09-30
• First posted: 2025-04-16
• Last updated: 2025-04-16

Locations

1 site across 1 country: Canada