Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart
Recruiting · NCT07092644 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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
Where it is running
1 location listed.
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy) - Roma, Italy