CompletedNot Applicable

Acute Maternal Hyperoxygenation for Fetal Transposition of the Great Arteries (TGA)

Canada34 participantsStarted 2018-09-20

Plain-language summary

This prospective study will examine whether transient maternal hyperoxygenation is useful as a diagnostic test to more accurately detect TGA patients with poor vs. good neonatal intra-cardiac mixing of blood, based on the in-utero response to oxygen exposure. This study is Health Canada regulated

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Fetus with simple TGA +/- small VSD * Intention of active postnatal management after birth Exclusion Criteria: * Fetus with complex form of TGA * Significant fetal arrhythmia * Major non-cardiac lesions * Maternal contraindications for fetal MRI

What they're measuring

Fetal intracardiac/ductal shunting measured by echocardiogram flow patterns and MRI fluximetry

Timeframe: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

Fetal pulmonary blood flow measured by MRI fluximetry

Timeframe: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

Neonatal outcomes

Timeframe: Intrauterine demise to hospital discharge, or up to 1 year of age if pulmonary hypertension exists

Trial details

NCT IDNCT03771534

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More TGA - Transposition of Great Arteries trials