NCT07092644 Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart
| NCT ID | NCT07092644 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2023-11-16 |
| Primary Completion | 2026-11 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The goal of this study is to describe the maternal hemodynamic parameters detected by UltraSonic Cardiac Output Monitor (USCOM®) in women carrying a fetus with a congenital heart disease (CHD) and to possibly describe an association between those parameters and the presence of a fetal cardiac anomaly. It will also learn about: * the number of cases of preeclampsia in our population of women carrying fetuses with CHD * the relationship between maternal hemodynamic profile and maternal and perinatal outcome * the associations between maternal hemodynamic parameters and the specific heart defect subtype * the relationship between maternal hemodynamic parameters and fetal cardiac parameters in our population. The haemodynamic evaluation will be performed at the time of diagnosis of CHD and then every two weeks until delivery. A further evaluation will be performed immediately after delivery (within 72 hours).
Eligibility Criteria
Inclusion Criteria: * Informed consent accepted * Maternal Age ≥ 18 years * Singleton pregnancy with a viable fetus at \>20 weeks of gestation, with a diagnosis of congenital heart disease detected on antenatal ultrasound assessment and postnatally confirmed Exclusion Criteria: * Multiple pregnancy * Pregnancy complicated by aneuploidy, genetic syndrome, or major structural fetal abnormality * Maternal congenital heart disease (GUCH) * Maternal known cardiac disease