Actively Recruiting
Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2026-05-12
174
Participants Needed
5
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mother aged 18 years or older
- Currently pregnant women
- Foetal diagnosis of critical cyanotic congenital heart disease
- Pregnancy between 28 and 38 weeks of gestation at enrollment
- Receiving medical follow-up in one of the specified hospitals
- At least 4 weeks since initial CHD diagnosis
- Social security affiliation in France
- Co-parent aged 18 years or older
- Co-parent of an expecting woman in the study
- Child with prenatal isolated complex CHD, born to participating mother
- Written consent from both parents for child participation
- Social security affiliation in France
You will not qualify if you...
- Participant refusal to participate
- Wish for medical termination of pregnancy
- CHD with other fetal conditions affecting neurodevelopment (e.g., genetic syndromes)
- Unable to understand or complete self-reports
- Major untreated psychiatric conditions in mother during consultation or evaluation
- Legal or judicial guardianship
- Severe psychiatric disorders in father or co-parent
- Child did not have surgery within 60 days of birth
- Genetic anomalies or brain malformations in child affecting assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hopital de Marseille la Timone
Marseille, France
Actively Recruiting
2
CHU de Montpellier
Montpellier, France
Actively Recruiting
3
Institut Saint Pierre
Palavas-les-Flots, France
Actively Recruiting
4
Hopital Necker Enfants Malades
Paris, France
Actively Recruiting
5
Hopital Haut Leveque
Pessac, France
Actively Recruiting
Research Team
J
Johanna Calderon, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here