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NCT Number: NCT06574386

Pregnancy in GUCH Patients

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?

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Restriction Fetal Growth Retardation Growth Disorders Heart Defects, Congenital Heart Diseases IUGR Infant Development Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Related Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione universitaria policlinico Agostino Gemelli

Roma, 00168, Italy

Location contact

Maria Grandinetti

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurodevelopmental assessment

Diagnostic Test

Neurodevelopmental assessment

Primary outcomes

  1. 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

  1. Physical examination of the mother (BMI)

    Time frame: 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

  2. Systolic and diastolic blood pressure of the mother during pregnancy

    Time frame: 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

  3. NYHA class progression during pregnancy (NYHA functional class)

    Time frame: 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

  4. Cardiologic assessment of the mother (Electrocardiogram):

    Time frame: 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).

  5. Cardiologic assesment of the mother (Echocardiography)

    Time frame: 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),

  6. Cardiologic assesment of the mother (24-hour Holter ECG)

    Time frame: 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)

  7. Cardiologic assesment of the mother (24-hour Holter BP)

    Time frame: 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).

  8. Assessment of foetal growth and weight (Subcutaneous Adipose Thickness SCAT)

    Time frame: 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

  9. Assessment of foetal oxygenation

    Time frame: 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

  10. Numbers of obstetric and maternal complications

    Time frame: 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)

  11. Cardiological evaluation of the fetus

    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 will be evaluated by foetal cardiotocography

  12. Physical examination in newborns

    Time frame: 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

  13. Newborn's health and vital signs

    Time frame: At birth

    Evaluated by Apgar score calculation

  14. Fetal metabolic condition

    Time frame: At birth

    Evaluated by umbilical artery blood gas analysis

  15. Cardiologic assessment in newborns (Electrocardiogram)

    Time frame: 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).

  16. Cardiologic assesment in newborns (Echocardiography)

    Time frame: 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)

  17. Neurological examination in newborns

    Time frame: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.

    Neurological evaluation will include cerebral ultrasound

  18. Neurodevelopmental assessment in newborns (Hammersmith Infant Neurological Examination)

    Time frame: 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

  19. Physical growth in newborns (BMI)

    Time frame: Performed at birth, three months, and twelve months of age.

    Weight and height will be combined to report BMI in kg/m^2

  20. Physical growth in newborns (head circumference in Cm)

    Time frame: Performed at birth, three months, and twelve months of age.

    It will be measured head circumference in centimeters

  21. Respiratory function in newborns

    Time frame: Performed at birth, three months, and twelve months of age.

    Performed pulmonary function tests and nitrogen washout.

Study contacts

Contact information is provided by the study sponsor or research team.

Grandinetti Maria

CONTACT

[email protected]

+39 3478555745/ 0630154241

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: PURE-HEART

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Aug 27, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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