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 range

18 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

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

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