An interventional study of Neurodevelopmental assessment in Congenital Heart Disease, Pregnancy Related and Infant Development, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic
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:
264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.
This study's planned enrollment of 70 is below the median of 101 across 117 interventional studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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Exclusion Criteria:
Newborns from mothers with congenital heart disease will be subjected to neurodevelopmental assessment
Diagnostic Test: Neurodevelopmental assessment
Neurodevelopmental assessment
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).
Time frame: Assessment in the first, second and third trimester of pregnancy
Physical examination of the mother (BMI)
Physical examination will be evaluated by weight and height combination to report BMI in kg/m\^2
Time frame: 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
Systolic an diastolic blood pressure will be evaluated in mmHg
Time frame: 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
Time frame: 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).
Time frame: 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),
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At birth
Fetal metabolic condition
Evaluated by umbilical artery blood gas analysis
Time frame: 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).
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Performed at birth, three months, and twelve months of age.
Respiratory function in newborns
Performed pulmonary function tests and nitrogen washout.
Time frame: Performed at birth, three months, and twelve months of age.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS