AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease

Recruitingn/aAges any - 50 YearsAllInstitut National de la Santรฉ Et de la Recherche โ€ฆ
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 neurodev

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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. Non-inclusion 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. Non-inclusion 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 the mother of a child diagnosed with CHD: 1\. The child has not undergone surgery within 60 days of birth. Exclusion Criteria for children with CHD: 1\. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.
๐Ÿ’Š

What it tests

  • Not listed
๐Ÿ“

Where

5 sites
Hopital de Marseille la Timone
Marseille, France
CHU de Montpellier
Montpellier, France
Institut Saint Pierre
Palavas-les-Flots, France
Hopital Necker Enfants Malades
Paris, France
Hopital Haut Leveque
Pessac, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy