Congenital Heart Disease
Conditions
Keywords
Preeclampsia, Congenital Heart Disease, Maternal Hemodynamic
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).
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).
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between maternal hemodynamic profile (Systemic vascular resistance) and perinatal outcome | 36 months | Maternal hemodynamic indices will be obtained using the USCOM® system: systemic vascular resistance (dynes/s/cm5) will be evaluated. |
| Correlation between maternal hemodynamic profile and perinatal outcome (gestational age at delivery) | 36 months | Perinatal outcome will be evaluated. Gestational age will be expressed as weeks and days at delivery. |
| Correlation between maternal hemodynamic profile and perinatal outcome (birthweight) | 36 months | Perinatal outcome will be evaluated. Birthweight will be expressed in grams. |
| Correlation between maternal hemodynamic profile and perinatal outcome (birthweight centile) | 36 months | Perinatal outcome will be evaluated. Birthweight centile will be expressed in centile. |
| Correlation between maternal hemodynamic profile and perinatal outcome (need of respiratory or cardiac support) | 36 months | Perinatal outcome will be evaluated, such as need of respiratory or cardiac support. |
| Correlation between maternal hemodynamic profile and perinatal outcome (neonatal intensive care unit admission) | 36 months | Perinatal outcome will be evaluated, such as neonatal intensive care unit admission. |
| Prevalence of cases of preeclampsia in our population of pregnancies complicated by congenital heart disease | 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. |
| Correlation between maternal hemodynamic profile and perinatal outcome (major neonatal complications) | 36 months | Perinatal outcome will be evaluated, such as major neonatal complications. |
| Correlation coefficients between the maternal hemodynamic parameters (Cardiac output) to the specific heart defect type | 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. |
| Correlation coefficients between the maternal hemodynamic parameters (Systemic vascular resistance) to the specific heart defect type | 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). |
| Correlation coefficients between the maternal hemodynamic parameters (Cardiac output) to the specific fetal heart parameters | 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. |
| Correlation coefficients between the maternal hemodynamic parameters (Systemic vascular resistance) to the specific fetal heart parameters | 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). |
| Correlation between maternal hemodynamic profile and perinatal outcome (number of days in neonatal intensive care unit) | 36 months | Perinatal outcome will be evaluated, such as number of days in neonatal intensive care unit. |
| Correlation between maternal hemodynamic profile (Cardiac Output) and perinatal outcome | 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. |
Countries
Italy
Contacts
Primary ContactSilvia Salvi
Backup ContactFederica Totaro Aprile
Outcome results
None listed