NCT06574386

Pregnancy in GUCH Patients

Pregnancy in GUCH Patients: Maternal-Foetal-Neonatal Aspects at Mid Term

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Detailed description

After being informed about the study and potential risks all patients giving written informed consent will undergo: * Cardiological and obstetric evaluation in the first trimester of pregnancy; * Cardiological and obstetric revaluation in the second trimester of pregnancy; * Cardiological and obstetric revaluation in the third trimester of pregnancy; * Cardiac and general neonatal evaluation at birth; * 2-year follow-up: maternal and neonatal cardiology evaluation, childhood neurodevelopment evaluation

Conditions

• Congenital Heart Disease
• Pregnancy Related
• Infant Development
• IUGR
• Fetal Growth Restriction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Neurodevelopmental assessment	Neurodevelopmental assessment

Timeline

• Start date: 2024-11-01
• Primary completion: 2027-10-01
• Completion: 2029-10-01
• First posted: 2024-08-27
• Last updated: 2024-10-22

Locations

1 site across 1 country: Italy