Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Study ID
NCT06711666
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Heart Disease
  • Cyanotic Congenital Heart Disease
  • Hypoplastic Left Heart Syndrome
  • d-Transposition of the Great Arteries

Eligibility Criteria

Sex
ALL
Age
N/A - 50 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Dec 2, 2024
Start date
Jun 27, 2025
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
174 participants (estimated)

Primary Outcome Measure

Global Mental Health Self-questionnaire, The Symptom Checklist-90-Revised SCL-90 R (min score 20 - max score 80) [ Time Frame: Time 1 Prenatal Visit and Time 3 1-year old Visit ]

Central Contacts

Related Studies