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NCT Number: NCT07092644

Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart

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).

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Roma, 00168, Italy

Location status: Recruiting

Location contact

Silvia Salvi

CONTACT

[email protected]

39 + 3397172786

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UltraSonic Cardiac Output Monitor (USCOM®)

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).

Primary outcomes

  1. Maternal hemodynamic parametrics changes (Cardiac Output, assessed by USCOM® system) in pregnancies complicated by congenital heart diseases and immediately after delivery

    Time frame: 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.

  2. Maternal hemodynamic parametrics changes (Systemic vascular resistance, assessed by USCOM® system) in pregnancies complicated by congenital heart diseases and immediately after delivery

    Time frame: 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.

Secondary outcomes

  1. Prevalence of cases of preeclampsia in our population of pregnancies complicated by congenital heart disease

    Time frame: 36 months

    According to the International Society for the Study of Hypertension in Pregnancy (ISSHP) 2018 criteria, 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.

  2. Correlation between maternal hemodynamic profile (Cardiac Output) and perinatal outcome

    Time frame: 36 months

    Maternal hemodynamic indices will be obtained using the USCOM® system: heart rate (HR) and stroke volume will be combined to report cardiac output (CO) in L/min.

  3. Correlation between maternal hemodynamic profile (Systemic vascular resistance) and perinatal outcome

    Time frame: 36 months

    Maternal hemodynamic indices will be obtained using the USCOM® system: systemic vascular resistance (dynes/s/cm5) will be evaluated.

  4. Correlation between maternal hemodynamic profile and perinatal outcome (gestational age at delivery)

    Time frame: 36 months

    Perinatal outcome will be evaluated. Gestational age will be expressed as weeks and days at delivery.

  5. Correlation between maternal hemodynamic profile and perinatal outcome (birthweight)

    Time frame: 36 months

    Perinatal outcome will be evaluated. Birthweight will be expressed in grams.

  6. Correlation between maternal hemodynamic profile and perinatal outcome (birthweight centile)

    Time frame: 36 months

    Perinatal outcome will be evaluated. Birthweight centile will be expressed in centile.

  7. Correlation between maternal hemodynamic profile and perinatal outcome (need of respiratory or cardiac support)

    Time frame: 36 months

    Perinatal outcome will be evaluated, such as need of respiratory or cardiac support.

  8. Correlation between maternal hemodynamic profile and perinatal outcome (neonatal intensive care unit admission)

    Time frame: 36 months

    Perinatal outcome will be evaluated, such as neonatal intensive care unit admission.

  9. Correlation between maternal hemodynamic profile and perinatal outcome (number of days in neonatal intensive care unit)

    Time frame: 36 months

    Perinatal outcome will be evaluated, such as number of days in neonatal intensive care unit.

  10. Correlation between maternal hemodynamic profile and perinatal outcome (major neonatal complications)

    Time frame: 36 months

    Perinatal outcome will be evaluated, such as major neonatal complications.

  11. Correlation coefficients between the maternal hemodynamic parameters (Cardiac output) to the specific heart defect type

    Time frame: 36 months

    The specific type of congenital heart defect, assessed using obstetric ultrasounds, will be related to maternal hemodynamic indices, assessed using the USCOM® system, such as Heart rate (HR) and stroke volume, combined to report cardiac output (CO) in L/min.

  12. Correlation coefficients between the maternal hemodynamic parameters (Systemic vascular resistance) to the specific heart defect type

    Time frame: 36 months

    The specific type of congenital heart defect, assessed using obstetric ultrasounds, will be related to maternal hemodynamic indices, assessed using the USCOM® system, such as systemic vascular resistance (dynes/s/cm5).

  13. Correlation coefficients between the maternal hemodynamic parameters (Cardiac output) to the specific fetal heart parameters

    Time frame: 36 months

    The specific fetal heart parameters (fetal cardiac function and morphologic features), assessed using obstetric ultrasounds, will be related to maternal hemodynamic indices, assessed using the USCOM® system, such as Heart rate (HR) and stroke volume, combined to report cardiac output (CO) in L/min.

  14. Correlation coefficients between the maternal hemodynamic parameters (Systemic vascular resistance) to the specific fetal heart parameters

    Time frame: 36 months

    The specific fetal heart parameters (fetal cardiac function and morphologic features), assessed using obstetric ultrasounds, will be related to maternal hemodynamic indices, assessed using the USCOM® system, such as systemic vascular resistance (dynes/s/cm5).

Study contacts

Contact information is provided by the study sponsor or research team.

Federica Totaro Aprile

CONTACT

[email protected]

39 + 3347347894

Silvia Salvi

CONTACT

[email protected]

39 + 3397172786

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Preeclampsia e Malformazioni Cardiache Fetali: Uno Sguardo al Cuore Materno

Acronym: MAMAH

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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