Pregnancy in GUCH Patients (PURE-HEART)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Not yet enrolling

Conditions

IUGR

Fetal Growth Restriction

Pregnancy Related

Congenital Heart Disease

Infant Development

Treatments

Diagnostic Test: Neurodevelopmental assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT06574386

6487

Details and patient eligibility

About

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?

Full 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

Enrollment

70 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.