Perinatal HypoxiaSTIMULUSNCT06930274
Stillbirth Risk Identification Using Multiparametric Ultrasound
An observational study of Perinatal Hypoxia, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Perinatal Hypoxia
- How many people
- 282 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jan 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Potential participants are recruited from the following sources: 1. South Community Birth Program 2. Maternal Fetal Medicine Clinics at BC Women's Hospital (EMMA and Fetal Monitoring)
Who may be able to join
- 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
Who cannot join
- Pregnant with multiples
- Not planning to deliver at BC Women's Hospital
- Less than 19 years of age
- Greater than 38 weeks gestation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
South Community Birth Program
Vancouver, British Columbia, V5V 3C9
Tiffany Reeve, MSc, 778-227-1243, treeve@mail.ubc.ca
About this study
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.
Read the 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
- Keywords
- Quantitative Ultrasound, Placenta, Stillbirth, Fetal Hypoxia
- Medical subject headings
- Stillbirth, Fetal Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Perinatal Hypoxia at 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. )
Measured: 35-37 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start3 Jan 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal HypoxiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Principal investigator, Robert Rohling, University of British Columbia
- Investigators
- Robert Rohling, PhD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930274
- Sponsor's protocol ID
- H22-02803
- Acronym
- STIMULUS
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stillbirth Risk Identification Using Multiparametric Ultrasound
- ClinicalTrials.gov ID
- NCT06930274
- Acronym / sponsor ID
- STIMULUS / H22-02803
- Conditions
- Perinatal Hypoxia
- Keywords
- Quantitative Ultrasound, Placenta, Stillbirth, Fetal Hypoxia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants are recruited from the following sources: 1. South Community Birth Program 2. Maternal Fetal Medicine Clinics at BC Women's Hospital (EMMA and Fetal Monitoring)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant with multiples
- Not planning to deliver at BC Women's Hospital
- Less than 19 years of age
- Greater than 38 weeks gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 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. )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Perinatal Hypoxia
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Recruiting
The HIEnome Study: Genome Sequencing for Perinatal HIE
Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy
Not yet recruitingPhase 2/3
Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
RecruitingObservational study
Baby Brain Recovery Study
Perinatal Stroke
Not yet recruitingPhase 1/2
Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Rohling, PhD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Hypoxia, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Reeve, MSc (778-227-1243, treeve@mail.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Perinatal Hypoxia at 35-37 weeks gestation (time frame: 35-37 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.