Pregnancy in GUCH Patients (PURE-HEART)

Pregnancy in GUCH Patients: Maternal-Foetal-Neonatal Aspects at Mid Term

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; Congenital Heart Disease; Infant Development; IUGR; Fetal Growth Restriction
• Intervention / Treatment: Diagnostic test: Neurodevelopmental assessment

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

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grandinetti Maria; Phone Number: +39 3478555745/ 0630154241; Email: maria.grandinetti@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione universitaria policlinico Agostino Gemelli
    • Contact: Maria Grandinetti; Email: maria.grandinetti@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Childhood neurodevelopment; Newborns from mothers with congenital heart disease will be subjected to neurodevelopmental assessment	Diagnostic test: Neurodevelopmental assessment; Neurodevelopmental assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Massimo Massetti, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; GUCH
• Additional Relevant MeSH Terms: Urogenital Diseases; Cardiovascular Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Fetal Diseases; Growth Disorders; Congenital Abnormalities; Cardiovascular Abnormalities; Fetal Growth Retardation; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 6487

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No