Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart

NCT ID: NCT07092644

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2026-11-30

Brief 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).

Detailed Description

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).

Conditions

Congenital Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Hemodynamic evaluation in pregnant women carring a fetus with a congenital heart desease

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.

Group Type: OTHER

UltraSonic Cardiac Output Monitor (USCOM®)

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Salvi Silvia

Medical Doctor Specialised in Obstetrics and Gyanecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Salvi

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome (Italy)

Locations

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

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Silvia Salvi

Role: CONTACT

silvia.salvi@policlinicogemelli.it

39 + 3397172786

Federica Totaro Aprile

Role: CONTACT

federica.totaroaprile01@icatt.it

39 + 3347347894

Facility Contacts

Silvia Salvi

Role: primary

silvia.salvi@policlinicogemelli.it

39 + 3397172786

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Ethic Committee Gemelli

Identifier Type: OTHER

Identifier Source: secondary_id

7552

Identifier Type: -

Identifier Source: org_study_id