Increasing oxygen for pregnant mothers with babies having congenital heart disease

Congenital Heart Disease (CHD): Hemodynamic Effects of Acute Maternal Hyperoxygenation in the Fetus

This study is testing if giving extra oxygen to pregnant women whose babies have congenital heart disease can help improve their babies' brain growth and development after birth.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: The Hospital for Sick Children (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT03944837 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of acute maternal hyperoxygenation on fetal cerebral oxygenation in pregnancies affected by congenital heart disease (CHD). By administering supplemental oxygen to mothers in the later stages of pregnancy, the research aims to assess whether this intervention can enhance fetal brain growth and improve neurodevelopmental outcomes postnatally. The study will utilize echocardiography and MRI to measure changes in fetal oxygen levels and identify which types of CHD may benefit most from this treatment approach.

Who should consider this trial

Good fit: Ideal candidates include pregnant mothers aged 18 and older carrying fetuses diagnosed with severe forms of congenital heart disease.

Not a fit: Patients who do not have a diagnosis of congenital heart disease or those with less severe forms of the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could lead to improved brain development and better cognitive outcomes for infants born with congenital heart disease.

How similar studies have performed: While the approach of maternal hyperoxygenation is novel, similar studies have shown promising results in enhancing fetal oxygenation and brain development.

Eligibility criteria

Inclusion Criteria:

* Pregnant mothers ≥18 years of age
* Written maternal informed consent
* Fetal diagnosis of one of the CHDs (1-3) as listed below and intention of active treatment after birth:

  1. Single ventricular (SV) lesions: hypoplastic left heart syndrome (HLHS); pulmonary atresia with intact ventricular septum (PA/IVS); tricuspid atresia (TA); unbalanced AV septal defect (AVSD); double inlet ventricle (DILV); and severe form of Ebstein's anomaly (EA) of the tricuspid valve associated with functional or anatomical right outflow obstruction. HLHS will include aortic stenosis with mitral stenosis, aortic atresia with mitral stenosis or mitral atresia. Pulmonary or aortic obstruction is defined as a condition with minimal or absent antegrade flow across the respective valve. Severe forms of EA is defined as lesion without anterograde pulmonary flow in the setting of severe tricuspid regurgitation.
  2. Bi-ventricular lesions with right ventricular outflow tract obstruction (BV/RVOTO); tetralogy of Fallot (TOF), TOF-like double outlet right ventricle (DORV), and pulmonary atresia with ventricular septal defect (PA/VSD).
  3. Bi-ventricular lesions with transposed great arteries (TGA w/ VSD; TGA w/o VSD; DORV with TGA)

Exclusion Criteria:

* Termination of pregnancy
* Unusual CHDs (e.g. EA with circular shunt, TOF with AVSD, and TOF with absent pulmonary valve syndrome, TGA associated with moderate- severe outflow tract obstruction
* Complex cardiac condition (e.g poor fetal cardiac function and/or fetal hydrops, fetal arrhythmia such as frequent premature atrial beats, abnormal baseline heart rate (\<110 bpm; \> 160 bpm) in the third trimester)
* Major non-cardiac lesions and major genetic abnormalities affecting brain size and development
* Significant maternal co-morbidities that precludes a fetal MRI (e.g. significant obesity, claustrophobia)
* Multiple pregnancy

Where this trial is running

Toronto, Ontario

• The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Edgar Jaeggi, MD, FRCP(C) — The Hospital for Sick Children
• Study coordinator: Edgar Jaeggi, MD, FRCP(C)

Conditions Congenital Heart Disease; Acute maternal hyperoxygenation; Echocardiography; MRI