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Congenital Heart DiseaseNCT03944837

Acute Maternal Hyperoxygenation in CHD

A study testing Oxygen gas in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Congenital heart disease (CHD) is predominantly detected before birth. Using echocardiography and MRI, this study will determine whether acute exposure to maternal hyperoxygenation (MH) leads to measurable increases in fetal cerebral oxygenation from baseline in fetuses with CHD. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Congenital Heart Disease
What is being tested?
Oxygen gas
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteCanada
Study dates
26 Apr 2019to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
  • 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).
  • Bi-ventricular lesions with transposed great arteries (TGA w/ VSD; TGA w/o VSD; DORV with TGA)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Hospital for Sick Children

    Toronto, Ontario, M5G1X8

Other trials in Canada

About this study

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

Congenital heart disease (CHD) is predominantly detected before birth. Using echocardiography and MRI, this study will determine whether acute exposure to maternal hyperoxygenation (MH) leads to measurable increases in fetal cerebral oxygenation from baseline in fetuses with CHD. The study aims to determine whether MH could be used as a chronic in-utero treatment strategy to promote brain growth/maturation to birth and to improve postnatal neurodevelopmental outcomes, and identify the types of CHD most likely to benefit from chronic MH.

Read the detailed description

This study determines the impact of administering oxygen to mother during the later part of pregnancy on cerebral oxygen delivery in fetuses who were identified with severe forms of Congenital Heart disease (CHD) including the following groups:

  • Group 1: Single ventricular (SV) lesions, including 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 with pulmonary atresia) of the tricuspid valve; and
  • Group 2: Tetralogy of Fallot (TOF),including TOF-like double outlet right ventricle (DORV), pulmonary atresia with ventricular septal defect (PA/VSD)
  • Group 3: Bi-ventricular lesions with transposition of the great arteries (TGA), including DORV with TGA

Children with severe CHD experience challenges in multiple developmental domains, impacting executive function, memory, language, and other aspects of cognitive and motor function. It is now well established that brain growth and development are adversely affected by CHD and it is increasingly clear that central nervous system changes that occur in the third trimester play a particularly important role in the pathogenesis of adverse neurodevelopmental outcomes.

Supplemental maternal oxygen will used in the last trimester for a short period of time (acute MH) in pregnant mothers carrying babies with CHD to briefly increase fetal oxygen levels to those reached in the newborn with spontaneous breathing. This study will examine whether and to what degree acute MH will improve the cerebrovascular oxygenation. The rate and duration of MH (10 to 15L/min by mask for up to 30-45 minutes/test) is considered to be safe to the mother and her fetus. Both fetal echocardiography and fetal MRI will be used to determine the effects of acute MH on the fetal-placental circulation and will determine in fetuses with CHD whether acute exposure to MH leads to measurable increases in fetal cerebral oxygenation from baseline. Thus it could potentially become useful as a chronic in-utero treatment strategy to promote brain growth/maturation to birth and to improve postnatal neurodevelopmental outcomes.

Being tested
Oxygen gas
Keywords
Acute maternal hyperoxygenation, Echocardiography, MRI
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxygen gasOther

    Transient maternal oxygen administration during echocardiographic and MRI imaging

Study groups in NCT03944837
Study groupRoleWhat they receive
Severe fetal congenital heart disease (CHD)ExperimentalMothers whose fetuses have a diagnosis of CHD will be exposed to 10-15 L/minute of oxygen while undergoing echocardiogaphy and MRI scanning
Receives: Other: Oxygen gas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Characterize the hemodynamic effects of acute MH on fetuses with a) SV lesions and biventricular anomalies b) with TOF and c) with TGA.

    The affect MH has on the cerebral oxygenation from baseline for each type of CHD will be characterized using the MRI variables of cerebral oxygen delivery (cDO2) and cerebral oxygen consumption(cVO2) , which are calculated using fluximetry measurements (ml/min/m2) and the oxymetry of the ascending aorta and the superior vena cava

    Measured: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

Secondary outcomes (1)

  1. Determine the pulmonary and placental vascular response to acute MH for each CHD

    The pulmonary and placental vascular response to acute MH for each CHD type will be measured using the placenta T2 star variable and the variables related to main pulmonary artery and branch pulmonary artery flow. Pulmonary vaso-reactivity to oxygen by echocardiography defined by a decrease the branch PA PI of ≥10%.

    Measured: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2019
  2. Study start26 Apr 2019
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03944837
Sponsor's protocol ID
1000062939
Status last verified
Apr 2026
First submitted
29 Apr 2019
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oxygen gas in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Characterize the hemodynamic effects of acute MH on fetuses with a) SV lesions and biventricular anomalies b) with TOF and c) with TGA. (time frame: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03944837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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