Stillbirth Risk Identification Using Multiparametric Ultrasound

NCT06930274 | Recruiting

• 1 other identifier: H22-02803
• Study Type: observational
• Target: 282
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Hypoxia

Keywords

Quantitative Ultrasound; Placenta; Stillbirth; Fetal Hypoxia

Outcome Measures

Primary Outcomes (1)

• Presence of Perinatal Hypoxia at 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. )

  35-37 weeks gestation

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• Pregnant with singleton
• Age 19 years or older
• Provision of informed consent
• Planning to deliver at BC Women's Hospital
• weeks gestation or less

You may not qualify if:

• Pregnant with multiples
• Not planning to deliver at BC Women's Hospital
• Less than 19 years of age
• Greater than 38 weeks gestation

Sponsors & Collaborators

• University of British Columbia: lead
• Wellcome Trust: collaborator

Study Sites (1)

South Community Birth Program

Vancouver, British Columbia, V5V 3C9, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

placenta

MeSH Terms

Conditions

Stillbirth; Fetal Hypoxia

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Robert Rohling, PhD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Reeve, MSc

CONTACT

778-227-1243; treeve@mail.ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 16, 2025
• Study Start: January 3, 2023
• Primary Completion: July 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

CA (1)