Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease

Launched by INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE, FRANCE · Nov 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a mother's mental health during pregnancy affects the development of her child who has congenital heart disease (CHD). Specifically, it aims to understand whether stress, anxiety, or depression in expectant mothers has any impact on their child's development by the age of one, especially for those babies who will need heart surgery shortly after birth. The study also looks at other factors, like family background and the mental health of the father or co-parent, to see how they might influence outcomes.

To participate, mothers must be at least 18 years old, pregnant with a baby diagnosed with a severe form of CHD, and at least 28 weeks along in their pregnancy. Fathers or co-parents must also be 18 and willing to join the study. Participants will be followed from the third trimester of pregnancy until their child turns one year old. This research is important because it seeks to improve the long-term health and development of children with heart defects diagnosed before birth, helping families better understand the challenges they may face.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for the mother of a child diagnosed with CHD:
• • 1. Age at least 18 years old
• • 2. Expecting women
• • 3. 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).
• • 4. 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.
• • 5. Medical maternal and paediatric cardiology follow-up in one of the investigating hospitals (Montpellier, Necker Children's Hospital in Paris and Bordeaux).
• • 6. A delay of a minimum of 4 weeks between the initial diagnosis of foetal congenital heart disease.
• • 7. Social security affiliation in France.
• Inclusion criteria for the father or co-parent:
• • 1. Co-parent of an expecting woman participating in the study
• • 2. Age at least 18 years old
• • 3. Social security affiliation in France.
• Inclusion criteria for the child diagnosed with congenital heart disease:
• • 1. Child with a prenatal diagnosis of isolated complex congenital heart disease, born to a mother already participating in the study
• • 2. Written consent from both parents
• • 3. Social security affiliation in France.
• Exclusion Criteria for mothers:
• • 1. Patient refusal to participate
• • 2. Participants (i.e., expecting women) who express a wish for medical termination of pregnancy
• • 3. 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).
• • 4. Participants who are not able to understand the instructions and/or complete the self-reports
• • 5. 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.
• • 6. Persons under legal or judicial guardianship.
• Exclusion Criteria for fathers or co-parents:
• • 1. Patient refusal to participate
• • 2. Participants with a severe psychiatric disorder (severe depression, psychotic disorders) with or without treatment
• • 3. Persons under legal or judicial guardianship.
• Exclusion Criteria for children with CHD:
• • 1. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.