Status:
NOT_YET_RECRUITING
Pregnancy in GUCH Patients
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Congenital Heart Disease
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Detailed Description
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; * Car...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06574386
Start Date
November 1 2024
End Date
October 1 2029
Last Update
October 22 2024
Active Locations (1)
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1
Fondazione universitaria policlinico Agostino Gemelli
Roma, Italy, 00168