Prenatal maternal mental health and infant brain development in congenital heart defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, longitudinal observational study enrolling expecting mothers after 28 weeks gestation who have received a prenatal diagnosis of a critical cyanotic congenital heart defect requiring neonatal open-heart surgery. Participants undergo comprehensive maternal psychological evaluations by perinatal mental health professionals and standardized self-report measures, with co-parents completing questionnaires at baseline. Assessments occur at three time points: late pregnancy, before neonatal hospital discharge after surgery, and at the child's first birthday (12–18 months). The study follows children from the third trimester through their first year to relate prenatal parental mental health to early neurodevelopmental and behavioral outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hopital de Marseille la Timone
  Marseille, France Recruiting
• CHU de Montpellier
  Montpellier, France Recruiting
• Institut Saint Pierre
  Palavas-les-Flots, France Recruiting
• Hopital Necker Enfants Malades
  Paris, France Recruiting
• Hopital Haut Leveque
  Pessac, France Recruiting

Study contacts

• Study coordinator: Johanna Calderon, PhD
• Email: johanna.calderon@inserm.fr
• Phone: 330603830737

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.