Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07092644

Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-07-30

108

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

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).

CONDITIONS

Official Title

Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Informed consent accepted
  • Maternal age 18 years or older
  • Singleton pregnancy with a viable fetus at more than 20 weeks of gestation
  • Diagnosis of congenital heart disease detected on antenatal ultrasound and confirmed after birth
Not Eligible

You will not qualify if you...

  • Multiple pregnancy
  • Pregnancy with aneuploidy, genetic syndrome, or major structural fetal abnormality
  • Maternal congenital heart disease (GUCH)
  • Known maternal cardiac disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Roma, Italy, 00168

Actively Recruiting

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Research Team

S

Silvia Salvi

CONTACT

F

Federica Totaro Aprile

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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