Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for pregnant women whose unborn baby has a serious heart defect needing open-heart surgery soon after birth. Their partners and the babies can also join.

Életkor

Mothers and co-parents: at least 18 years, up to 50 years. Children join from birth.

Nem

All. Mothers must be pregnant. Fathers or co-parents of any sex can join.

A betegség stádiuma

The unborn baby has a critical cyanotic heart defect, a type that can lower blood oxygen after birth. The defect must be complex and occur alone. The mother must be between 28 and 38 weeks of pregnancy. The diagnosis must have been made at least 4 weeks before.

Korábbi kezelés

The baby must have heart surgery within 60 days of birth.

A részvétel fő kizáró okai

• The baby has a genetic syndrome (such as a trisomy), several malformations or a brain malformation
• The mother wishes to end the pregnancy for medical reasons
• A parent has a major or severe mental illness, treated or not
• A parent is under legal or court guardianship
• A parent cannot understand the instructions or fill in the questionnaires

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.