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Stillbirth Risk Identification Using Multiparametric Ultrasound

Stillbirth Risk Identification Using Multiparametric Ultrasound

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06930274
Acronym
STIMULUS
Enrollment
282
Registered
2025-04-16
Start date
2023-01-03
Completion date
2025-09-30
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Hypoxia

Keywords

Quantitative Ultrasound, Placenta, Stillbirth, Fetal Hypoxia

Brief 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.

Interventions

None listed

Sponsors

Wellcome Trust
CollaboratorOTHER
University of British Columbia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Pregnant with singleton 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

1. Pregnant with multiples 2. Not planning to deliver at BC Women's Hospital 3. Less than 19 years of age 4. Greater than 38 weeks gestation

Design outcomes

Primary

MeasureTime frameDescription
Presence of Perinatal Hypoxia at 35-37 weeks gestation35-37 weeks gestationPerinatal hypoxia is defined as meeting one or more of the following: 1. Apgar \< 7 at 5 minutes 2. Umbilical artery pH \< 7.1 3. Neonatal cardiac resuscitation performed (includes CPAP, intubation and ventilation, or cardiopulmonary resuscitation) 4. 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. )

Countries

Canada

Contacts

Primary ContactTiffany Reeve, MSc
treeve@mail.ubc.ca778-227-1243

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026