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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?
After being informed about the study and potential risks all patients giving written informed consent will undergo:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Childhood neurodevelopment | Experimental | Newborns from mothers with congenital heart disease will be subjected to neurodevelopmental assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurodevelopmental assessment | Diagnostic Test | Neurodevelopmental assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical examination of the mother (BMI) | Physical examination will be evaluated by weight and height combination to report BMI in kg/m^2 | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth |
| Systolic and diastolic blood pressure of the mother during pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grandinetti Maria | Contact | +39 3478555745/ 0630154241 | maria.grandinetti@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Massimo Massetti | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione universitaria policlinico Agostino Gemelli | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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Systolic an diastolic blood pressure will be evaluated in mmHg |
| Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth |
| NYHA class progression during pregnancy (NYHA functional class) | NYHA class will be evalueted by medical examination during pregnancy | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth |
| Cardiologic assessment of the mother (Electrocardiogram): | Cardiologic assesment will be evaluated by the use of Electrocardiogram (PR, QRS, QTc intervals and ST segment changes). | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth |
| Cardiologic assesment of the mother (Echocardiography) | Cardiologic assesment will be evaluated by the use of echocardiography (wall motion assessment and residual congenital heart disease), | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth |
| Cardiologic assesment of the mother (24-hour Holter ECG) | Cardiologic assesment will be evaluated by the use of 24-hour Holter ECG (ventricular and atrial arrhythmic burden) | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth |
| Cardiologic assesment of the mother (24-hour Holter BP) | Cardiologic assesment will be evaluated by the use of 24-hour Holter BP (degree of arterial hypertension). | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth |
| Assessment of foetal growth and weight (Subcutaneous Adipose Thickness SCAT) | Evaluated by abdominal adipose thickness index | Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery. |
| Assessment of foetal oxygenation | Foetal oxygenation will be evaluated by rterial doppler of uterine arteries, umbilical arteries and middle cerebral artery and venous doppler of the umbilical vein and ductus venosus | Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery. |
| Numbers of obstetric and maternal complications | Incidence of obstetric and maternal complications (maternal mortality, cardiac complications, hypertensive disorders, gestational diabetes, hepatosis, sepsis, placental abruption, thromboembolic events, postpartum haemorrhage, disseminated intravascular coagulation, need for further hospitalization; evaluation of mode of delivery) | Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery. |
| Cardiological evaluation of the fetus | Cardiological evaluation of the fetus will be evaluated by foetal cardiotocography | Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery. |
| Physical examination in newborns | Physical examination will be evaluated by weight and height combination to report BMI in kg/m^2 | Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth |
| Newborn's health and vital signs | Evaluated by Apgar score calculation | At birth |
| Fetal metabolic condition | Evaluated by umbilical artery blood gas analysis | At birth |
| Cardiologic assessment in newborns (Electrocardiogram) | Cardiologic assesment will be evaluated by the use of Electrocardiogram (PR, QRS, QTc intervals and ST segment changes). | Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth. |
| Cardiologic assesment in newborns (Echocardiography) | Cardiologic assesment will be evaluated by the use of echocardiography (will be examined cardiac anatomical assessment; functional evaluation with left ventricular diastolic function and systolic function (EF and FS); right ventricular function; global function (MPI), PFO, PDA, pulmonary artery pressure, cardiac output, and input) | Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth. |
| Neurological examination in newborns | Neurological evaluation will include cerebral ultrasound | Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth. |
| Neurodevelopmental assessment in newborns (Hammersmith Infant Neurological Examination) | Neurological examination according to the Hammersmith Neonatal Neurological Examination | Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth. |
| Physical growth in newborns (BMI) | Weight and height will be combined to report BMI in kg/m^2 | Performed at birth, three months, and twelve months of age. |
| Physical growth in newborns (head circumference in Cm) | It will be measured head circumference in centimeters | Performed at birth, three months, and twelve months of age. |
| Respiratory function in newborns | Performed pulmonary function tests and nitrogen washout. | Performed at birth, three months, and twelve months of age. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |