Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart

Recruiting now · Not applicable

Conditions studied: Congenital Heart Disease

In brief

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).

Key facts

Study ID

NCT07092644

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

108

Starts

2023-11-16

Expected to finish

2026-11-01

Last updated by the study team

2025-07-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy) — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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