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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country70 target enrollmentNovember 1, 2024

ConditionsCongenital Heart Disease Pregnancy Related Infant Development IUGR Fetal Growth Restriction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Congenital Heart Disease
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment: 70
Locations: 1
Primary Endpoint: Neonatal outcomes in terms of weight and appropriate intrauterine development
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

November 1, 2024

End Date

October 1, 2029

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Responsible Party

Sponsor

Eligibility Criteria

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 +
•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.

Outcomes

Primary Outcomes

Neonatal outcomes in terms of weight and appropriate intrauterine development

Time Frame: 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 Outcomes

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)
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)
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)
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 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 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 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)
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.)
Assessment of foetal oxygenation(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(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(Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.)
Physical examination in newborns(Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth)
Newborn's health and vital signs(At birth)
Fetal metabolic condition(At birth)
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 in newborns (Echocardiography)(Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.)
Neurological examination in newborns(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)(Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.)
Physical growth in newborns (BMI)(Performed at birth, three months, and twelve months of age.)
Physical growth in newborns (head circumference in Cm)(Performed at birth, three months, and twelve months of age.)
Respiratory function in newborns(Performed at birth, three months, and twelve months of age.)