Stillbirth Risk Identification Using Multiparametric Ultrasound

NCT ID: NCT06930274

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

282 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-03

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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Perinatal Hypoxia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wellcome Trust

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Robert Rohling

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Rohling, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

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South Community Birth Program

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Tiffany Reeve, MSc

Role: CONTACT

778-227-1243

Facility Contacts

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Tiffany Reeve, MSc

Role: primary

778-227-1243

Other Identifiers

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H22-02803

Identifier Type: -

Identifier Source: org_study_id

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