Pregnancy in GUCH Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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?
Eligibility criteria
Qualifiers
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)
Disqualifiers
Maternal chromosomal abnormalities.
Maternal syndromic conditions.
Spontaneous abortion.
Vanishing Twin.
Trial design
Treatments tested in this trial
- Neurodevelopmental assessment
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov