RecruitingNot ApplicableNCT07092644

Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart

Preeclampsia e Malformazioni Cardiache Fetali: Uno Sguardo al Cuore Materno


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

108 participants

Start Date

Nov 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • Multiple pregnancy
  • Pregnancy complicated by aneuploidy, genetic syndrome, or major structural fetal abnormality
  • Maternal congenital heart disease (GUCH)
  • Maternal known cardiac disease

Interventions

DEVICEUltraSonic Cardiac Output Monitor (USCOM®)

Using USCOM, the haemodynamic evaluation will be performed at the time of diagnosis of congenital heart desease and then every two weeks until delivery. A further evaluation will be performed immediately after delivery (within 72 hours).


Locations(1)

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

Roma, Italy

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NCT07092644


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