Moms' stress in pregnancy linked to baby brain outcomes in heart defect study
NCT ID NCT06711666
First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 3 times
Summary
This study looks at 174 mothers whose babies were diagnosed with serious heart defects before birth. Researchers will track the mothers' mental health from the third trimester until the baby is one year old, and then test the babies' brain development. The goal is to understand if a mother's stress, anxiety, or depression during pregnancy affects how her child's brain grows after heart surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help identify ways to support mothers' mental health during pregnancy to improve brain development in children with heart defects.
- What could go wrong
- This is an observational study, not a treatment trial. It will not directly test any intervention, so results may only suggest associations, not causes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 174 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Expecting women diagnosed with a foetal complex congenital heart disease. Fathers or co-parent of prenatally diagnosed children with CHD Children with complex congenital heart disease who require neonatal open-heart surgery.
- Ages
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Up to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for the mother of a child diagnosed with CHD: 1. Age at least 18 years old 2. Expecting women 3. Having received a diagnosis of foetal critical cyanotic CHD (i.e., CHD physiology that can compromise blood oxygenation after birth). This type of CHDs corresponds to the highest level of neurological risk as reported by the American Heart Association guidelines(1). 4. Pregnancy of at least 28 weeks of gestation (third trimester) and up to the 38 weeks of gestation at the time of enrolment and prenatal visit for the study. 5. Medical maternal and paediatric cardiology follow-up in one of the investigating hospitals (Montpellier, Necker Children's Hospital in Paris and Bordeaux). 6. A delay of a minimum of 4 weeks between the initial diagnosis of foetal congenital heart disease. 7. Social security affiliation in France. Inclusion criteria for the father or co-parent: 1. Co-parent of an expecting woman participating in the study 2. Age at least 18 years old 3. Social security affiliation in France. Inclusion criteria for the child diagnosed with congenital heart disease: 1. Child with a prenatal diagnosis of isolated complex congenital heart disease, born to a mother already participating in the study 2. Written consent from both parents 3. Social security affiliation in France. Non-inclusion Criteria for mothers: 1. Patient refusal to participate 2. Participants (i.e., expecting women) who express a wish for medical termination of pregnancy 3. Diagnosis of a complex CHD associated with another foetal comorbidity with a clinically recognized impact on neurodevelopment (e.g., genetic syndromes such as trisomies, poly-malformation syndromes). 4. Participants who are not able to understand the instructions and/or complete the self-reports 5. Expecting women who currently have a major psychiatric condition (e.g., untreated major depression, severe anxiety disorders, psychotic disorders) with or without treatment, at the time of the cardiology consultation or at the time of the first psychological evaluation. Patients who will be excluded due to these conditions will be referred for perinatal psychiatric consultation. 6. Persons under legal or judicial guardianship. Non-inclusion Criteria for fathers or co-parents: 1. Patient refusal to participate 2. Participants with a severe psychiatric disorder (severe depression, psychotic disorders) with or without treatment 3. Persons under legal or judicial guardianship. Exclusion Criteria for the mother of a child diagnosed with CHD: 1\. The child has not undergone surgery within 60 days of birth. Exclusion Criteria for children with CHD: 1\. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Montpellier
RECRUITINGMontpellier, France
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Hopital Haut Leveque
RECRUITINGPessac, France
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Hopital Necker Enfants Malades
RECRUITINGParis, France
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Hopital de Marseille la Timone
RECRUITINGMarseille, France
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Institut Saint Pierre
RECRUITINGPalavas-les-Flots, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a gentler breathing machine protect young hearts and brains after surgery?
- A soft patch that watches your heart beat in real time
- Can a warm wrist make baby arterial lines easier?
- Why fontan hearts struggle to exercise: researchers probe the lungs
- Can a scan before birth predict a Baby's heart defect?