Pregnancy in GUCH Patients

NCT06574386 | Not Yet Recruiting

• 1 other identifier: 6487
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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?

Conditions

Congenital Heart Disease; Pregnancy Related; Infant Development; IUGR; Fetal Growth Restriction

Keywords

GUCH; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• 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

Study Arms (1)

Childhood neurodevelopment

EXPERIMENTAL

Newborns from mothers with congenital heart disease will be subjected to neurodevelopmental assessment

Diagnostic Test: Neurodevelopmental assessment

Interventions

Neurodevelopmental assessment DIAGNOSTIC_TEST

Neurodevelopmental assessment

Childhood neurodevelopment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione universitaria policlinico Agostino Gemelli

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Massetti

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grandinetti Maria

CONTACT

+39 3478555745/ 0630154241; maria.grandinetti@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 27, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: October 22, 2024

Record last verified: 2024-08

Locations

IT (1)