Taking peopleNo phase

Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease

Key facts

Who runs it: Institut National de la Santé Et de la Recherche Médicale, France
Where: France5 sites in 1 countryChoose a country to see its sites
Trial code: NCT06711666
Status: Recruiting
People taking part: 174 people, planned
Started: 27 Jun 2025
Expected to end: Feb 2029
Type of study: Observational
Record updated: 30 July 2026

Who can take part

Age: Up to 50 years
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

Age at least 18 years old
Expecting women
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)
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
Medical maternal and paediatric cardiology follow-up in one of the investigating hospitals (Montpellier, Necker Children's Hospital in Paris and Bordeaux)
A delay of a minimum of 4 weeks between the initial diagnosis of foetal congenital heart disease
Social security affiliation in France
Co-parent of an expecting woman participating in the study
Age at least 18 years old
Social security affiliation in France
Child with a prenatal diagnosis of isolated complex congenital heart disease, born to a mother already participating in the study
Written consent from both parents
Social security affiliation in France; Non-inclusion Criteria for mothers:
Patient refusal to participate
Participants (i.e., expecting women) who express a wish for medical termination of pregnancy
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)
Participants who are not able to understand the instructions and/or complete the self-reports
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
Persons under legal or judicial guardianship; Non-inclusion Criteria for fathers or co-parents:
Patient refusal to participate
Participants with a severe psychiatric disorder (severe depression, psychotic disorders) with or without treatment
Persons under legal or judicial guardianship

Who cannot take part

The child has not undergone surgery within 60 days of birth
Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Congenital heart disease (CHD) is the leading cause of congenital malformations, representing 1% of live births. Progress in surgical care have led to the dramatic increase in the population of children and adults living with heart disease. As survival is no longer a concern, long-term outcomes have become the major public health issue. Prenatal diagnosis of CHD requiring open-heart surgery can be a traumatic event for expecting mothers and fathers. In the general population, maternal mental health distress is associated with fetal disturbances in the hypothalamic-adrenal-pituitary system axis, restricted intrauterine growth and adverse outcomes in the offspring. It is unknown whether prenatal maternal psychological distress have an impact on neurodevelopmental outcomes in CHD. Our national study seeks to (1) characterize the impact of prenatal maternal psychological distress on neurodevelopmental outcomes at age 1 for children with CHD who undergo neonatal open-heart surgery; (2) investigate the sociodemographic and medical determinants associated with prenatal maternal mental health of women carrying a foetus diagnosed with complex CHD; (3) explore the mediating role of prenatal risk factors (i.e., sociodemographic, medical and maternal coping mechanisms) in the association of prenatal maternal mental health (i.e., distress, anxiety and depression) and neurodevelopment in children with CHD; and (4) explore the impact of paternal or the co-parent's mental health impact on neurodevelopmental outcomes at age 1 in children with CHD. This study is a non-interventional, prospective, and longitudinal study of prenatal maternal mental health and subsequent child's neurodevelopmental and behavioural outcomes. It includes a follow-up period from the 3rd trimester of pregnancy until the child's first year of life. It will include children with a prenatally diagnosed heart defect requiring open-heart surgery within the first weeks of life. Understanding and preventing the neurodevelopmental sequelae of heart disease diagnosed in-utero is a public health priority.