NCT03771534

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

Transposition of the Great Arteries: Prenatal Anatomical and Hemodynamic Findings Associated With Perinatal Outcomes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a prospective pilot study to examine whether transient maternal hyperoxygenation is useful as a diagnostic test to more accurately detect TGA patients with poor vs. good neonatal intracardiac mixing of blood, based on the in-utero response to oxygen exposure. Acute maternal oxygen administration will transiently increase the fetal oxygen levels to those reached at birth with spontaneous breathing, thus simulating conditions that will naturally occur at the time of birth. Echocardiogram and MRI will be used to examine the effects on the fetal circulation. The prenatal findings will then be compared to the neonatal presentation. The investigators postulate that conditions that predispose newborns to acute neonatal compromise will be detectable and distinguishable prior to birth by echocardiography, MRI, or by combining the findings of both exams.

Conditions

• TGA - Transposition of Great Arteries

Interventions

Type	Name	Description
DRUG	Oxygen gas	Brief maternal administration of 65-70% O2 via a face mask during the last trimester

Timeline

• Start date: 2018-09-20
• Primary completion: 2024-08-31
• Completion: 2025-01-31
• First posted: 2018-12-11
• Last updated: 2024-01-31

Locations

1 site across 1 country: Canada