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Not yet taking people in ItalyNo phase

Pregnancy in GUCH Patients

Key facts

Who runs it
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Where
Roma, ItalySee the site
Trial code
Status
Not yet recruiting
People taking part
70 people, planned
Started
1 Nov 2024
Expected to end
1 Oct 2029
Type of study
Interventional
Treatments tested
  • Neurodevelopmental assessment
Record updated
22 October 2024

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • Maternal syndromic conditions
  • Maternal chromosomal abnormalities
  • 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

Where in Italy

  • Fondazione universitaria policlinico Agostino GemelliRoma, ItalyContact: Maria GrandinettiNo longer taking part

About the trial

What the trial wants to find out

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.

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The main question it aims to answer is:

-Does maternal congenital heart disease affects outcomes of newborn?

The group in the trial

  • Childhood neurodevelopmentTreatment being tested

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

    Treatment: Neurodevelopmental assessment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Pregnancy in GUCH Patients: Maternal-Foetal-Neonatal Aspects at Mid Term
Record updated
22 October 2024