Stillbirth Risk Identification Using Multiparametric Ultrasound

University of British Columbia282 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

282

Conditions

Perinatal Hypoxia

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

South Community Birth Program

Vancouver, British Columbia, Canada

RECRUITING

Outcomes

Primary Outcomes

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. )

Time frame: 35-37 weeks gestation

Central Contacts

Tiffany Reeve, MSc

CONTACT

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

Data from ClinicalTrials.gov

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