Congenital Heart Disease, Fetal Growth Restriction, Infant Development, IUGR, Pregnancy Related
Conditions
Keywords
GUCH, Pregnancy
Brief 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
Interventions
DIAGNOSTIC_TESTNeurodevelopmental assessment
Neurodevelopmental assessment
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal outcomes in terms of weight and appropriate intrauterine development | Assessment in the first, second and third trimester of pregnancy | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical examination of the mother (BMI) | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth | Physical examination will be evaluated by weight and height combination to report BMI in kg/m\^2 |
| Systolic and diastolic blood pressure of the mother during pregnancy | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth | Systolic an diastolic blood pressure will be evaluated in mmHg |
| NYHA class progression during pregnancy (NYHA functional class) | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth | NYHA class will be evalueted by medical examination during pregnancy |
| Cardiologic assesment of the mother (Echocardiography) | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth | Cardiologic assesment will be evaluated by the use of echocardiography (wall motion assessment and residual congenital heart disease), |
| Cardiologic assesment of the mother (24-hour Holter ECG) | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth | Cardiologic assesment will be evaluated by the use of 24-hour Holter ECG (ventricular and atrial arrhythmic burden) |
| Cardiologic assesment of the mother (24-hour Holter BP) | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth | Cardiologic assesment will be evaluated by the use of 24-hour Holter BP (degree of arterial hypertension). |
| Assessment of foetal growth and weight (Subcutaneous Adipose Thickness SCAT) | Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery. | Evaluated by abdominal adipose thickness index |
| Assessment of foetal oxygenation | Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery. | 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 |
| Numbers of obstetric and maternal complications | Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery. | 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) |
| Cardiological evaluation of the fetus | 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 will be evaluated by foetal cardiotocography |
| Cardiologic assessment of the mother (Electrocardiogram): | Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth | Cardiologic assesment will be evaluated by the use of Electrocardiogram (PR, QRS, QTc intervals and ST segment changes). |
| Newborn's health and vital signs | At birth | Evaluated by Apgar score calculation |
| Fetal metabolic condition | At birth | Evaluated by umbilical artery blood gas analysis |
| Cardiologic assessment in newborns (Electrocardiogram) | Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth. | Cardiologic assesment will be evaluated by the use of Electrocardiogram (PR, QRS, QTc intervals and ST segment changes). |
| Cardiologic assesment in newborns (Echocardiography) | Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth. | 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) |
| Neurological examination in newborns | Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth. | Neurological evaluation will include cerebral ultrasound |
| Neurodevelopmental assessment in newborns (Hammersmith Infant Neurological Examination) | Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth. | Neurological examination according to the Hammersmith Neonatal Neurological Examination |
| Physical growth in newborns (BMI) | Performed at birth, three months, and twelve months of age. | Weight and height will be combined to report BMI in kg/m\^2 |
| Physical growth in newborns (head circumference in Cm) | Performed at birth, three months, and twelve months of age. | It will be measured head circumference in centimeters |
| Respiratory function in newborns | Performed at birth, three months, and twelve months of age. | Performed pulmonary function tests and nitrogen washout. |
| Physical examination in newborns | Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth | Physical examination will be evaluated by weight and height combination to report BMI in kg/m\^2 |
Countries
Italy
Contacts
Primary ContactGrandinetti Maria
Outcome results
None listed