Congenital Heart DiseaseMAMAHNCT07092644
Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart
A study testing UltraSonic Cardiac Output Monitor (USCOM®) in people with Congenital Heart Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- UltraSonic Cardiac Output Monitor (USCOM®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 16 Nov 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Multiple pregnancy
- Pregnancy complicated by aneuploidy, genetic syndrome, or major structural fetal abnormality
- Maternal congenital heart disease (GUCH)
- Maternal known cardiac disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy)
Roma, 00168
Silvia Salvi, 39 + 3397172786, silvia.salvi@policlinicogemelli.it
About this study
Official title: Preeclampsia e Malformazioni Cardiache Fetali: Uno Sguardo al Cuore Materno
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:
Read more
- 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).
Read the 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
- Being tested
- UltraSonic Cardiac Output Monitor (USCOM®)
- Keywords
- Preeclampsia, Congenital Heart Disease, Maternal Hemodynamic
- Medical subject headings
- Heart Defects, Congenital, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic evaluation in pregnant women carring a fetus with a congenital heart desease | Other | 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. Receives: Device: UltraSonic Cardiac Output Monitor (USCOM®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal hemodynamic parametrics changes (Cardiac Output, assessed by USCOM® system) in pregnancies complicated by congenital heart diseases and immediately after delivery
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.
Measured: 36 months
Maternal hemodynamic parametrics changes (Systemic vascular resistance, assessed by USCOM® system) in pregnancies complicated by congenital heart diseases and immediately after delivery
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.
Measured: 36 months
Secondary outcomes (14)
Prevalence of cases of preeclampsia in our population of pregnancies complicated by congenital heart disease
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.
Measured: 36 months
Correlation between maternal hemodynamic profile (Cardiac Output) and perinatal outcome
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.
Measured: 36 months
Correlation between maternal hemodynamic profile (Systemic vascular resistance) and perinatal outcome
Maternal hemodynamic indices will be obtained using the USCOM® system: systemic vascular resistance (dynes/s/cm5) will be evaluated.
Measured: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (gestational age at delivery)
Perinatal outcome will be evaluated. Gestational age will be expressed as weeks and days at delivery.
Measured: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (birthweight)
Perinatal outcome will be evaluated. Birthweight will be expressed in grams.
Measured: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (birthweight centile)
Perinatal outcome will be evaluated. Birthweight centile will be expressed in centile.
Measured: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (need of respiratory or cardiac support)
Perinatal outcome will be evaluated, such as need of respiratory or cardiac support.
Measured: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (neonatal intensive care unit admission)
Perinatal outcome will be evaluated, such as neonatal intensive care unit admission.
Measured: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (number of days in neonatal intensive care unit)
Perinatal outcome will be evaluated, such as number of days in neonatal intensive care unit.
Measured: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (major neonatal complications)
Perinatal outcome will be evaluated, such as major neonatal complications.
Measured: 36 months
Correlation coefficients between the maternal hemodynamic parameters (Cardiac output) to the specific heart defect type
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.
Measured: 36 months
Correlation coefficients between the maternal hemodynamic parameters (Systemic vascular resistance) to the specific heart defect type
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).
Measured: 36 months
Correlation coefficients between the maternal hemodynamic parameters (Cardiac output) to the specific fetal heart parameters
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.
Measured: 36 months
Correlation coefficients between the maternal hemodynamic parameters (Systemic vascular resistance) to the specific fetal heart parameters
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).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start16 Nov 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvi Silvia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Silvia Salvi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092644
- Sponsor's protocol ID
- 7552
- Other IDs
- Ethic Committee Gemelli
- Acronym
- MAMAH
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vinayagam D, Patey O, Thilaganathan B, Khalil A. Cardiac output assessment in pregnancy: comparison of two automated monitors with echocardiography. Ultrasound Obstet Gynecol. 2017 Jan;49(1):32-38. doi: 10.1002/uog.15915.
PubMed 26970353Hodgson LE, Venn R, Forni LG, Samuels TL, Wakeling HG. Measuring the cardiac output in acute emergency admissions: use of the non-invasive ultrasonic cardiac output monitor (USCOM) with determination of the learning curve and inter-rater reliability. J Intensive Care Soc. 2016 May;17(2):122-128. doi: 10.1177/1751143715619186. Epub 2015 Dec 10.
PubMed 28979476Brown MA, Magee LA, Kenny LC, Karumanchi SA, McCarthy FP, Saito S, Hall DR, Warren CE, Adoyi G, Ishaku S; International Society for the Study of Hypertension in Pregnancy (ISSHP). Hypertensive Disorders of Pregnancy: ISSHP Classification, Diagnosis, and Management Recommendations for International Practice. Hypertension. 2018 Jul;72(1):24-43. doi: 10.1161/HYPERTENSIONAHA.117.10803. No abstract available.
PubMed 29899139Melchiorre K, Giorgione V, Thilaganathan B. The placenta and preeclampsia: villain or victim? Am J Obstet Gynecol. 2022 Feb;226(2S):S954-S962. doi: 10.1016/j.ajog.2020.10.024. Epub 2021 Mar 24.
PubMed 33771361Masini G, Foo LF, Tay J, Wilkinson IB, Valensise H, Gyselaers W, Lees CC. Preeclampsia has two phenotypes which require different treatment strategies. Am J Obstet Gynecol. 2022 Feb;226(2S):S1006-S1018. doi: 10.1016/j.ajog.2020.10.052. Epub 2021 Jun 10.
PubMed 34774281Miremberg H, Gindes L, Schreiber L, Raucher Sternfeld A, Bar J, Kovo M. The association between severe fetal congenital heart defects and placental vascular malperfusion lesions. Prenat Diagn. 2019 Oct;39(11):962-967. doi: 10.1002/pd.5515. Epub 2019 Jul 17.
PubMed 31254468Thilaganathan B. Preeclampsia and Fetal Congenital Heart Defects: Spurious Association or Maternal Confounding? Circulation. 2017 Jul 4;136(1):49-51. doi: 10.1161/CIRCULATIONAHA.117.028816. No abstract available.
PubMed 28674092Boyd HA, Basit S, Behrens I, Leirgul E, Bundgaard H, Wohlfahrt J, Melbye M, Oyen N. Association Between Fetal Congenital Heart Defects and Maternal Risk of Hypertensive Disorders of Pregnancy in the Same Pregnancy and Across Pregnancies. Circulation. 2017 Jul 4;136(1):39-48. doi: 10.1161/CIRCULATIONAHA.116.024600. Epub 2017 Apr 19.
PubMed 28424221Auger N, Fraser WD, Healy-Profitos J, Arbour L. Association Between Preeclampsia and Congenital Heart Defects. JAMA. 2015 Oct 20;314(15):1588-98. doi: 10.1001/jama.2015.12505.
PubMed 26501535Brodwall K, Leirgul E, Greve G, Vollset SE, Holmstrom H, Tell GS, Oyen N. Possible Common Aetiology behind Maternal Preeclampsia and Congenital Heart Defects in the Child: a Cardiovascular Diseases in Norway Project Study. Paediatr Perinat Epidemiol. 2016 Jan;30(1):76-85. doi: 10.1111/ppe.12252. Epub 2015 Oct 19.
PubMed 26479038Llurba E, Sanchez O, Ferrer Q, Nicolaides KH, Ruiz A, Dominguez C, Sanchez-de-Toledo J, Garcia-Garcia B, Soro G, Arevalo S, Goya M, Suy A, Perez-Hoyos S, Alijotas-Reig J, Carreras E, Cabero L. Maternal and foetal angiogenic imbalance in congenital heart defects. Eur Heart J. 2014 Mar;35(11):701-7. doi: 10.1093/eurheartj/eht389. Epub 2013 Oct 24.
PubMed 24159191Taylor RN, Grimwood J, Taylor RS, McMaster MT, Fisher SJ, North RA. Longitudinal serum concentrations of placental growth factor: evidence for abnormal placental angiogenesis in pathologic pregnancies. Am J Obstet Gynecol. 2003 Jan;188(1):177-82. doi: 10.1067/mob.2003.111.
PubMed 12548214Hertig A, Berkane N, Lefevre G, Toumi K, Marti HP, Capeau J, Uzan S, Rondeau E. Maternal serum sFlt1 concentration is an early and reliable predictive marker of preeclampsia. Clin Chem. 2004 Sep;50(9):1702-3. doi: 10.1373/clinchem.2004.036715. No abstract available.
PubMed 15331514Levine RJ, Maynard SE, Qian C, Lim KH, England LJ, Yu KF, Schisterman EF, Thadhani R, Sachs BP, Epstein FH, Sibai BM, Sukhatme VP, Karumanchi SA. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med. 2004 Feb 12;350(7):672-83. doi: 10.1056/NEJMoa031884. Epub 2004 Feb 5.
PubMed 14764923Burton GJ, Woods AW, Jauniaux E, Kingdom JC. Rheological and physiological consequences of conversion of the maternal spiral arteries for uteroplacental blood flow during human pregnancy. Placenta. 2009 Jun;30(6):473-82. doi: 10.1016/j.placenta.2009.02.009. Epub 2009 Apr 17.
PubMed 19375795
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preeclampsia e Malformazioni Cardiache Fetali: Uno Sguardo al Cuore Materno
- ClinicalTrials.gov ID
- NCT07092644
- Acronym / sponsor ID
- MAMAH / 7552
- Conditions
- Congenital Heart Disease
- Keywords
- Preeclampsia, Congenital Heart Disease, Maternal Hemodynamic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic evaluation in pregnant women carring a fetus with a congenital heart desease | Other | Device: UltraSonic Cardiac Output Monitor (USCOM®)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Multiple pregnancy
- Pregnancy complicated by aneuploidy, genetic syndrome, or major structural fetal abnormality
- Maternal congenital heart disease (GUCH)
- Maternal known cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Hemodynamic evaluation in pregnant women carring a fetus with a congenital heart desease |
Primary outcome
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.
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.
14 secondary outcomes
Prevalence of cases of preeclampsia in our population of pregnancies complicated by congenital heart disease
Time frame: 36 months
Correlation between maternal hemodynamic profile (Cardiac Output) and perinatal outcome
Time frame: 36 months
Correlation between maternal hemodynamic profile (Systemic vascular resistance) and perinatal outcome
Time frame: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (gestational age at delivery)
Time frame: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (birthweight)
Time frame: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (birthweight centile)
Time frame: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (need of respiratory or cardiac support)
Time frame: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (neonatal intensive care unit admission)
Time frame: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (number of days in neonatal intensive care unit)
Time frame: 36 months
Correlation between maternal hemodynamic profile and perinatal outcome (major neonatal complications)
Time frame: 36 months
Correlation coefficients between the maternal hemodynamic parameters (Cardiac output) to the specific heart defect type
Time frame: 36 months
Correlation coefficients between the maternal hemodynamic parameters (Systemic vascular resistance) to the specific heart defect type
Time frame: 36 months
Correlation coefficients between the maternal hemodynamic parameters (Cardiac output) to the specific fetal heart parameters
Time frame: 36 months
Correlation coefficients between the maternal hemodynamic parameters (Systemic vascular resistance) to the specific fetal heart parameters
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 26970353Vinayagam D, Patey O, Thilaganathan B, Khalil A. Cardiac output assessment in pregnancy: comparison of two automated monitors with echocardiography. Ultrasound Obstet Gynecol. 2017 Jan;49(1):32-38. doi: 10.1002/uog.15915.
- Background: PubMed 28979476Hodgson LE, Venn R, Forni LG, Samuels TL, Wakeling HG. Measuring the cardiac output in acute emergency admissions: use of the non-invasive ultrasonic cardiac output monitor (USCOM) with determination of the learning curve and inter-rater reliability. J Intensive Care Soc. 2016 May;17(2):122-128. doi: 10.1177/1751143715619186. Epub 2015 Dec 10.
- Background: PubMed 29899139Brown MA, Magee LA, Kenny LC, Karumanchi SA, McCarthy FP, Saito S, Hall DR, Warren CE, Adoyi G, Ishaku S; International Society for the Study of Hypertension in Pregnancy (ISSHP). Hypertensive Disorders of Pregnancy: ISSHP Classification, Diagnosis, and Management Recommendations for International Practice. Hypertension. 2018 Jul;72(1):24-43. doi: 10.1161/HYPERTENSIONAHA.117.10803. No abstract available.
- Background: PubMed 33771361Melchiorre K, Giorgione V, Thilaganathan B. The placenta and preeclampsia: villain or victim? Am J Obstet Gynecol. 2022 Feb;226(2S):S954-S962. doi: 10.1016/j.ajog.2020.10.024. Epub 2021 Mar 24.
- Background: PubMed 34774281Masini G, Foo LF, Tay J, Wilkinson IB, Valensise H, Gyselaers W, Lees CC. Preeclampsia has two phenotypes which require different treatment strategies. Am J Obstet Gynecol. 2022 Feb;226(2S):S1006-S1018. doi: 10.1016/j.ajog.2020.10.052. Epub 2021 Jun 10.
- Background: PubMed 31254468Miremberg H, Gindes L, Schreiber L, Raucher Sternfeld A, Bar J, Kovo M. The association between severe fetal congenital heart defects and placental vascular malperfusion lesions. Prenat Diagn. 2019 Oct;39(11):962-967. doi: 10.1002/pd.5515. Epub 2019 Jul 17.
- Background: PubMed 28674092Thilaganathan B. Preeclampsia and Fetal Congenital Heart Defects: Spurious Association or Maternal Confounding? Circulation. 2017 Jul 4;136(1):49-51. doi: 10.1161/CIRCULATIONAHA.117.028816. No abstract available.
- Background: PubMed 28424221Boyd HA, Basit S, Behrens I, Leirgul E, Bundgaard H, Wohlfahrt J, Melbye M, Oyen N. Association Between Fetal Congenital Heart Defects and Maternal Risk of Hypertensive Disorders of Pregnancy in the Same Pregnancy and Across Pregnancies. Circulation. 2017 Jul 4;136(1):39-48. doi: 10.1161/CIRCULATIONAHA.116.024600. Epub 2017 Apr 19.
- Background: PubMed 26501535Auger N, Fraser WD, Healy-Profitos J, Arbour L. Association Between Preeclampsia and Congenital Heart Defects. JAMA. 2015 Oct 20;314(15):1588-98. doi: 10.1001/jama.2015.12505.
- Background: PubMed 26479038Brodwall K, Leirgul E, Greve G, Vollset SE, Holmstrom H, Tell GS, Oyen N. Possible Common Aetiology behind Maternal Preeclampsia and Congenital Heart Defects in the Child: a Cardiovascular Diseases in Norway Project Study. Paediatr Perinat Epidemiol. 2016 Jan;30(1):76-85. doi: 10.1111/ppe.12252. Epub 2015 Oct 19.
- Background: PubMed 24159191Llurba E, Sanchez O, Ferrer Q, Nicolaides KH, Ruiz A, Dominguez C, Sanchez-de-Toledo J, Garcia-Garcia B, Soro G, Arevalo S, Goya M, Suy A, Perez-Hoyos S, Alijotas-Reig J, Carreras E, Cabero L. Maternal and foetal angiogenic imbalance in congenital heart defects. Eur Heart J. 2014 Mar;35(11):701-7. doi: 10.1093/eurheartj/eht389. Epub 2013 Oct 24.
- Background: PubMed 12548214Taylor RN, Grimwood J, Taylor RS, McMaster MT, Fisher SJ, North RA. Longitudinal serum concentrations of placental growth factor: evidence for abnormal placental angiogenesis in pathologic pregnancies. Am J Obstet Gynecol. 2003 Jan;188(1):177-82. doi: 10.1067/mob.2003.111.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Salvi principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UltraSonic Cardiac Output Monitor (USCOM®) in people with Congenital Heart Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Salvi (39 + 3397172786, silvia.salvi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07092644, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.