Pregnancy in GUCH Patients

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Aug 26, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Pregnancy in GUCH Patients," is designed to explore how congenital heart diseases in mothers can affect both their health during pregnancy and the health of their babies. Specifically, the study will look at whether a mother's heart condition impacts the outcomes for newborns, as well as how pregnancy influences the mother's heart health. The research will follow mothers and their babies for up to two years after birth to gather important information.

To participate in this study, women must be at least 18 years old, have a history of congenital heart disease (either naturally occurring or after surgery), and be experiencing a single pregnancy that is developing normally at around 14 weeks. Participants will need to provide informed consent and have had normal results from early pregnancy tests and ultrasounds. This trial is not currently recruiting participants, so it is important to stay informed about when it begins. Overall, the study aims to gather valuable insights that could help improve the care and outcomes for mothers with congenital heart disease and their children.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.