Clinical trial NCT06574386: Pregnancy in GUCH Patients
Official title: Pregnancy in GUCH Patients: Maternal-Foetal-Neonatal Aspects at Mid Term
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Pregnancy Related
Infant Development
IUGR
Fetal Growth Restriction
Keywords: GUCH
Pregnancy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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 + 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.

Primary outcomes:
measure: Neonatal outcomes in terms of weight and appropriate intrauterine development
timeFrame: Assessment in the first, second and third trimester of pregnancy
Secondary outcomes:
measure: Physical examination of the mother (BMI)
timeFrame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
measure: Systolic and diastolic blood pressure of the mother during pregnancy
timeFrame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
measure: NYHA class progression during pregnancy (NYHA functional class)
timeFrame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
measure: Cardiologic assessment of the mother (Electrocardiogram):
timeFrame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
measure: Cardiologic assesment of the mother (Echocardiography)
timeFrame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
measure: Cardiologic assesment of the mother (24-hour Holter ECG)
timeFrame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
measure: Cardiologic assesment of the mother (24-hour Holter BP)
timeFrame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
measure: Assessment of foetal growth and weight (Subcutaneous Adipose Thickness SCAT)
timeFrame: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
measure: Assessment of foetal oxygenation
timeFrame: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
measure: Numbers of obstetric and maternal complications
timeFrame: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
measure: Cardiological evaluation of the fetus
timeFrame: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
measure: Physical examination in newborns
timeFrame: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth
measure: Newborn's health and vital signs
timeFrame: At birth
measure: Fetal metabolic condition
timeFrame: At birth
measure: Cardiologic assessment in newborns (Electrocardiogram)
timeFrame: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
measure: Cardiologic assesment in newborns (Echocardiography)
timeFrame: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
measure: Neurological examination in newborns
timeFrame: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
measure: Neurodevelopmental assessment in newborns (Hammersmith Infant Neurological Examination)
timeFrame: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
measure: Physical growth in newborns (BMI)
timeFrame: Performed at birth, three months, and twelve months of age.
measure: Physical growth in newborns (head circumference in Cm)
timeFrame: Performed at birth, three months, and twelve months of age.
measure: Respiratory function in newborns
timeFrame: Performed at birth, three months, and twelve months of age.
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione universitaria policlinico Agostino Gemelli
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Massimo Massetti
role: PRINCIPAL_INVESTIGATOR
References: