Condition: Congenital Heart Disease · Cyanotic Congenital Heart Disease · d-Transposition of the Great Arteries · Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
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 ne…
This description comes directly from the study's public registry record.
Johanna Calderon, PhD · 330603830737 · johanna.calderon@inserm.fr
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT06711666