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NCT Number: NCT06930274

Stillbirth Risk Identification Using Multiparametric Ultrasound

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.

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Key information

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Primary location

South Community Birth Program

Vancouver, British Columbia, V5V 3C9, Canada

Location status: Recruiting

Location contact

Tiffany Reeve, MSc

CONTACT

[email protected]

778-227-1243

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Presence of Perinatal Hypoxia at 35-37 weeks gestation

    Time frame: 35-37 weeks gestation

    Perinatal hypoxia is defined as meeting one or more of the following:

    • Apgar < 7 at 5 minutes
    • Umbilical artery pH < 7.1
    • Neonatal cardiac resuscitation performed (includes CPAP, intubation and ventilation, or cardiopulmonary resuscitation)
    • Neonatal encephalopathy (Severe brain injury diagnosed within the first 7 days of life defined as: was therapeutically cooled; and/or had decreased central tone or was comatose and had seizures of any kind; and/or had amplitude integrated electroencephalography (aEEG abnormality) in the first 24 hours of birth. )

Study contacts

Contact information is provided by the study sponsor or research team.

Tiffany Reeve, MSc

CONTACT

[email protected]

778-227-1243

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Wellcome Trust

Registry information

Acronym: STIMULUS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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