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

Launched by THE HOSPITAL FOR SICK CHILDREN · Dec 7, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a method called maternal hyperoxygenation, which means giving extra oxygen to pregnant women for a short time, to see if it can help doctors better understand how well a baby's heart is mixing blood before birth, specifically in cases of a heart condition known as Transposition of the Great Arteries (TGA). TGA is a serious condition where the heart's main arteries are switched, which can affect how blood flows through the body. The goal is to identify whether the baby has good or poor blood mixing, which can guide doctors on how to manage the baby’s care right after birth.

To be eligible for this study, participants must be pregnant women carrying a fetus with simple TGA (and possibly a small hole in the heart) and plan for active medical care for the baby after delivery. Unfortunately, if the fetus has a more complex form of TGA, serious heart rhythm issues, major non-heart problems, or if there are health concerns that prevent the mother from having a special type of imaging called MRI, they won’t be able to participate. Women who join the study can expect to undergo the hyperoxygenation process, which will help gather important information about their baby’s condition before birth. This study is currently recruiting participants and is regulated by Health Canada to ensure safety and effectiveness.

Gender

FEMALE

Eligibility criteria

• 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