Pregnancy in GUCH Patients

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT06574386
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neurodevelopmental assessment — DIAGNOSTIC_TEST
    Neurodevelopmental assessment

Study Details

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?

Key Dates

First listed
Aug 27, 2024
Start date
Nov 1, 2024
Status verified
Aug 2024
Primary completion
Oct 1, 2027
Completion
Oct 1, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Childhood neurodevelopment
    Newborns from mothers with congenital heart disease will be subjected to neurodevelopmental assessment

Primary Outcome Measure

Neonatal outcomes in terms of weight and appropriate intrauterine development [ Time Frame: Assessment in the first, second and third trimester of pregnancy ]

Central Contacts

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