Pregnancy in GUCH Patients
NCT Number: NCT06574386
Acronym: PURE HEART
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Congenital Heart Disease|Pregnancy Related|Infant Development|IUGR|Fetal Growth Restriction
Interventions: DIAGNOSTIC_TEST: Neurodevelopmental assessment
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10-01
Completion Date: 2029-10-01
Locations: Fondazione universitaria policlinico Agostino Gemelli, Roma, 00168, Italy

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?

Primary Outcome Measures: Neonatal outcomes in terms of weight and appropriate intrauterine development, Observation of neonatal outcome in terms of incidence of foetal growth restriction (FGR), defined as deviation from genetic potential with neonates classified as small for gestational age (SGA) or adequate for gestational age (AGA)., Assessment in the first, second and third trimester of pregnancy
Secondary Outcome Measures: Impact of pregnancy on maternal cardiac health, Cardiologic assessment of the mother including:

* Clinical assessment: physical examination, vital signs, Blood Pressure, Oxygen Saturation, NYHA functional class, baseline mWHO class;
* Instrumental assessment including: Electrocardiogram, Echocardiogram, 24-hour Holter ECG, 24-hour Holter BP, Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth|Impact of GUCH heart disease on maternal and foetal-neonatal health, Obstetric assessment including:

* Assessment of foetal growth and weight (abdominal adipose thickness index);
* Assessment of foetal oxygenation: arterial doppler of uterine arteries, umbilical arteries, middle cerebral artery and venous doppler of the umbilical vein and ductus venosus;
* Evaluation of foetal cardiotocography;
* Obstetric complications: late abortion, intrauterine death, preterm birth, premature rupture of membranes (pPROM);
* Evaluation of mode of delivery;
* Maternal morbidity during pregnancy and postpartum: cardiac complications, hypertensive disorders, gestational diabetes, hepatosis, sepsis, placental abruption, thromboembolic events, postpartum haemorrhage, disseminated intravascular coagulation (DIC), need for further hospitalization;
* Maternal mortality during pregnancy and postpartum., Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.|General, Cardiologic and neurodevelopmental assessment in newborns, Neonatal assessment including:

* General evaluation: biometric parameters, Apgar score, umbilical artery blood gas analysis at birth)
* Cardiac evaluation: ECG and Echocardiogram
* Neurological evaluation: cerebral ultrasound and neurological examination according to the Hammersmith Neonatal Neurological Examination
* Growth and respiratory function evaluation in the first 2 years of life: biometric parameters, pulmonary function tests and nitrogen washout, Neonatal cardiac and neurological evaluations will be performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.