Using oxygen to improve diagnosis of fetal heart condition TGA
Transposition of the Great Arteries: Prenatal Anatomical and Hemodynamic Findings Associated With Perinatal Outcomes
This study is testing if giving extra oxygen to pregnant women can help doctors better diagnose a heart condition in their unborn babies called transposition of the great arteries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 1 site (Toronto) |
| Trial ID | NCT03771534 on ClinicalTrials.gov |
What this trial studies
This prospective pilot study investigates the effectiveness of transient maternal hyperoxygenation as a diagnostic tool for detecting fetal transposition of the great arteries (TGA). By administering oxygen to the mother, the study aims to simulate the oxygen levels that the fetus would experience at birth, allowing for a better assessment of fetal circulation through echocardiography and MRI. The findings from these imaging techniques will be compared to the neonatal presentation to identify potential complications before birth.
Who should consider this trial
Good fit: Ideal candidates include fetuses diagnosed with simple TGA and whose care team intends to actively manage their condition postnatally.
Not a fit: Patients with complex forms of TGA, significant fetal arrhythmias, or major non-cardiac lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved prenatal diagnosis and management of TGA, potentially enhancing neonatal outcomes.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto
- The Hospital For Sick Children — Toronto, Canada (Recruiting)
Study contacts
- Principal investigator: Edgar Jaeggi, MD — The Hospital for Sick Children, Toronto
- Study coordinator: Edgar Jaeggi, MD
- Email: edgar.jaeggi@sickkids.ca
- Phone: +1(416)813-7500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.