Antenatal Investigation of Fetuses With Complex Congenital Heart Defects Using multiOMICS

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at unborn babies (fetuses) who have complex congenital heart defects (CHD) to better understand what might be causing these heart problems. Researchers will study the influence of environmental factors during pregnancy on these conditions. They are currently recruiting pregnant women who are at least 18 years old and are carrying a single baby with a complex heart defect that is not linked to any known genetic disorders or infections. To be eligible, participants should be between 20 and 28 weeks pregnant and agree to a procedure called amniocentesis, which involves taking a small sample of amniotic fluid for testing.

Participants in the trial can expect to provide informed consent and undergo the necessary tests related to this research. The study aims to uncover important information that could help in understanding congenital heart defects better, potentially leading to improved care and outcomes for affected babies. It's important to note that women with multiple pregnancies, those who do not understand French, or those who are under guardianship are not eligible to participate in this study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Fetuses with congenital heart disease :
• • Pregnant women aged 18 and more
• • Single foetal pregnancy in which the foetus has a complex non-syndromic congenital heart defect, with no identified chromosomal abnormality, gene syndrome or infection.
• • Patient for whom the indication for amniocentesis has been accepted by the CPDPN and accepted by the couple/patient
• • Gestational age between 20 and 28 weeks' gestation.
• • Person affiliated to or benefiting from a social security scheme.
• • Free, informed and express consent (confirmed in writing) (at the latest on the day of inclusion and before any examination required by the research).
• • Control Population for RNAseq and MéthlySeq
• • Pregnant women aged 18 and more
• • Patient in whom the indication for amniocentesis has been retained by the CPDPN and accepted by the couple/patient, for a non-malformative ultrasound anomaly (hyperechoic bowel, idiopathic hydramnios, increased risk of trisomy 21, agenesis of the OPN, suspected toxoplasmosis/CMV seroconversion), with no chromosomal anomaly, gene syndrome or infection identified.
• • Gestational age between 20 and 28 weeks' gestation.
• • Person affiliated to or benefiting from a social security scheme.
• • Free, informed and express consent (confirmed in writing) (at the latest on the day of inclusion and before any examination required by the research).
• Exclusion Criteria:
• For both populations (cases and controls) :
• • Female minors,
• • Patients not affiliated to the social security system,
• • Patients who do not understand French,
• • Patients under guardianship
• • Multiple pregnancies, or where the foetus has associated malformations