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Clinical Trials in Italy / NCT06574386
Starting soon Not applicable

Pregnancy in GUCH Patients

NCT06574386 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-11-01
Last updated
2024-10-22

Condition(s) studied

Congenital Heart DiseasePregnancy RelatedInfant DevelopmentIUGRFetal Growth Restriction

Investigational drug(s) / intervention(s)

Neurodevelopmental assessment

Neurodevelopmental assessment: Neurodevelopmental assessment

Study summary

This study aims to investigate the impact of congenital heart diseases on maternal and foetal-neonatal health, the effect of pregnancy on maternal cardiac health, and the outcome of newborns/children born from Grown-Up Congenital Heart (GUCH) mothers with follow-up at one year, extendable to two.

The main question it aims to answer is:

-Does maternal congenital heart disease affects outcomes of newborn?

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Congenital heart disease in natural history or undergoing corrective and/or palliative cardiothoracic surgery. * Chronological age \> 18 years. * Single pregnancy progressing normally at a gestational age of 14 weeks + 0. * Correct pregnancy dating based on CRL as per ISUOG guidelines. (26) * Normal results of non-invasive screening tests for foetal aneuploidies. * Normal first-trimester ultrasound examination. * Informed consent of the woman. Exclusion Criteria: * Maternal chromosomal abnormalities. * Maternal syndromic conditions. * Spontaneous abortion. * Vanishing Twin. * High risk for chromosomal abnormalities on screening tests performed in the 1st Trimester (Combined Test/NIPT) or Major foetal structural anomalies identified during first-trimester ultrasound evaluation.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione universitaria policlinico Agostino Gemelli Roma Italy

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06574386 on ClinicalTrials.gov ↗ ← All trials in Italy