UltraSonic 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).
Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Maternal hemodynamic parametrics changes (Cardiac Output, assessed by USCOM® system) in pregnancies complicated by congenital heart diseases and immediately after delivery — 36 months Hemodynamic indices will be obtained using the USCOM® system. Women will undergo a hemodynamic investigation at the time of first diagnosis of congenital heart disease during pregnancy or at the first assessment in Fondazione Policlinico A. Gemelli during pregnancy and then every two weeks until delivery. An additional hemodynamics evaluation will be performed in the post-partum period (in the 72 hours immediately after delivery). All hemodynamic assessment will be performed under standardized conditions. Heart rate (HR) and stroke volume will be combined to report cardiac output (CO) in L/min.
Maternal hemodynamic parametrics changes (Systemic vascular resistance, assessed by USCOM® system) in pregnancies complicated by congenital heart diseases and immediately after delivery — 36 months Hemodynamic indices will be obtained using the USCOM® system. Women will undergo a hemodynamic investigation at the time of first diagnosis of congenital heart disease during pregnancy or at the first assessment in Fondazione Policlinico A. Gemelli during pregnancy and then every two weeks until delivery. An additional hemodynamics evaluation will be performed in the post-partum period (in the 72 hours immediately after delivery). All hemodynamic assessment will be performed under standardized conditions. Systemic vascular resistance (dynes/s/cm5) will be evaluated.
Trial sites (1)
Facility
City
Region
Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy)
Roma
Italy
Recruiting
More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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