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Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart
NCT07092644 · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Official title
Preeclampsia e Malformazioni Cardiache Fetali: Uno Sguardo al Cuore Materno
About this study
The following maternal hemodynamic indices will be evaluated: heart rate (HR) (beats per min; bpm), mean arterial pressure (mmHg), stroke volume (mL), cardiac output (CO) (L/min), systemic vascular resistance (dynes/s/cm5). Data on the demographic and pregnancy characteristics of participants, hemodynamic and ultrasound investigations, perinatal and delivery features will be also collected. In particular, the following variables will be included in the study: type of congenital heart defect, gestational age at diagnosis, fetal weight (EFW) and fetal weight centile at diagnosis of CHD and at the last scan before delivery, mean uterine arteries pulsatility index (UtA-PI), fetal umbilical artery (UA-PI) and middle cerebral artery pulsatility index (MCA-PI) at diagnosis and at the last scan before delivery, maternal age, height, pre-pregnancy weight and gestational weight gain, systolic and diastolic blood pressure values (maximum and minimum values), presence of proteinuria, biochemical maternal assessment (maximun and miminum values of creatinine and uric acid level, platelet count, liver enzyme level), incidence of hypertensive disorders of pregnancy, antihypertensive drug administration (type and dosage) including magnesium sulfate, antenatal steroid administration, mode of delivery and indications, gestational age at delivery, birthweight and birthweight centile, need of respiratory or cardiac support, neonatal intensive care unit admission and number of days, major neonatal complications, maternal morbidities (HELLP, eclampsia, intravascular disseminate coagulation, post-partum hemorrhage), and mortality. The following definitions of hypertensive disorders will be used, according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) 2018 criteria (14): chronic hypertension (CH) will be defined as hypertension (≥140/90mmHg) that predates pregnancy or is present prior to 20 weeks' gestation; gestational hypertension was defined as de-novo hypertension (≥ 140/90 mmHg) after 20 weeks' gestation; and preeclampsia (PE) will be defined as de-novo hypertension (≥ 140/90 mmHg) after 20 weeks' gestation with coexisting proteinuria, other maternal organ dysfunction or fetal growth restriction; preeclampsia superimposed to chronic hypertension (PE-CH).
Eligibility criteria
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
Study design
Enrollment target: 108 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-11-16
Estimated completion: 2026-11
Last updated: 2025-07-30
Interventions
Device: UltraSonic Cardiac Output Monitor (USCOM®)
Primary outcomes
- • Maternal hemodynamic parametrics changes (Cardiac Output, assessed by USCOM® system) in pregnancies complicated by congenital heart diseases and immediately after delivery (36 months)
- • Maternal hemodynamic parametrics changes (Systemic vascular resistance, assessed by USCOM® system) in pregnancies complicated by congenital heart diseases and immediately after delivery (36 months)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · other
Contacts & investigators
ContactSilvia Salvi · contact · silvia.salvi@policlinicogemelli.it · 39 + 3397172786
ContactFederica Totaro Aprile · contact · federica.totaroaprile01@icatt.it · 39 + 3347347894
InvestigatorSilvia Salvi · principal_investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome (Italy)
All locations (1)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy)Recruiting
Roma, Italy