Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease

NCT06711666 | Recruiting

• 2 other identifiers: C23-222024-A02138-39
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

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

Keywords

psychological stress; Maternal prenatal mental health; Neurodevelopment; Cyanotic congenital heart disease; Prenatal diagnosis

Outcome Measures

Primary Outcomes (2)

• Global Mental Health Self-questionnaire, The Symptom Checklist-90-Revised SCL-90 R (min score 20 - max score 80)

  Mental Health Self-Report, Higher scores indicate worse outcomes

  Time 1 Prenatal Visit and Time 3 1-year old Visit

• Bayley Scales of Infant and Toddler Development (BAYLEY-4) (min score 50- max score 150)

  Standardized Neurodevelopmental Assessment, Higher scores better outcome, Mean 100; SD 15

  Time 3 1-year old Visit

Secondary Outcomes (5)

• State-Trait Anxiety Inventory (STAI-Y) (min score 20 - max score 80)

  Time 1 Prenatal Visit, Time 2 immediately after the neonatal open-heart surgery during postoperative hospitalization, Postoperative Visit and Time 3 1-year old Visit

• Coping Inventory for Stressful Situations (CISS), (min score 20 - max score 80)

  Time 1 Prenatal Visit and Time 3 1-year old Visit

• Post-partum depression Edinburgh Scale (EPDS) (min score 0 - max score 30)

  Time 2 immediately after the neonatal open-heart surgery during postoperative hospitalization, Postoperative Visit

• Post-Traumatic Stress Scale (PCL-5), (min score 0 - max score 80)

  Time 3 1-year old Visit

• Ages and Stages Parent Report, 3rd Edition (min score 0 - max score 60)

  Time 3 1-year old Visit

Eligibility Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Expecting women diagnosed with a foetal complex congenital heart disease. Fathers or co-parent of prenatally diagnosed children with CHD Children with complex congenital heart disease who require neonatal open-heart surgery.

You may qualify if:

• Age at least 18 years old
• Expecting women
• 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).
• 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.
• Medical maternal and paediatric cardiology follow-up in one of the investigating hospitals (Montpellier, Necker Children's Hospital in Paris and Bordeaux).
• A delay of a minimum of 4 weeks between the initial diagnosis of foetal congenital heart disease.
• Social security affiliation in France.
• Co-parent of an expecting woman participating in the study
• Age at least 18 years old
• Social security affiliation in France.
• Child with a prenatal diagnosis of isolated complex congenital heart disease, born to a mother already participating in the study
• Written consent from both parents
• Social security affiliation in France.

You may not qualify if:

• Patient refusal to participate
• Participants (i.e., expecting women) who express a wish for medical termination of pregnancy
• 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).
• Participants who are not able to understand the instructions and/or complete the self-reports
• 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.
• Persons under legal or judicial guardianship.
• Patient refusal to participate
• Participants with a severe psychiatric disorder (severe depression, psychotic disorders) with or without treatment
• Persons under legal or judicial guardianship.
• \. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (5)

Hopital de Marseille la Timone

Marseille, France

NOT YET 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

Related Publications (1)

• Deninotti J, Derridj N, Martins S, Laux D, Stos B, Levy M, Desnous B, Guillaumont S, Amedro P, Chabaneix J, Pfister M, Marguin G, Desmure G, Vincenti M, Bonnet D, Calderon J. Prenatal maternal mental health and neurodevelopment in congenital heart disease in France: the neuro-moms CHD multicentre prospective study protocol. BMJ Open. 2025 Dec 23;15(12):e104889. doi: 10.1136/bmjopen-2025-104889.

  PMID: 41436266 DERIVED

Related Links

• Video Neuro-Moms CHD

MeSH Terms

Conditions

Heart Defects, Congenital; Hypoplastic Left Heart Syndrome; Stress, Psychological

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavioral Symptoms; Behavior

Central Study Contacts

Johanna Calderon, PhD

CONTACT

330603830737; johanna.calderon@inserm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 2, 2024
• Study Start: June 27, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

FR (5)