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| ID | Type | Description | Link |
|---|---|---|---|
| Ethic Committee Gemelli | Other Identifier | 7552 |
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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 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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia Salvi | Contact | 39 + 3397172786 | silvia.salvi@policlinicogemelli.it | |
| Federica Totaro Aprile | Contact | 39 + 3347347894 | federica.totaroaprile01@icatt.it |
| Name | Affiliation | Role |
|---|---|---|
| Silvia Salvi | Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy) | Recruiting | Roma | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26970353 | Background | 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. | |
| 28979476 | Background | Hodgson 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2025 | Jun 21, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 24, 2025 | Jul 11, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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|
| 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. | 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. | 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. | 36 months |
| Correlation between maternal hemodynamic profile and perinatal outcome (birthweight) | Perinatal outcome will be evaluated. Birthweight will be expressed in grams. | 36 months |
| Correlation between maternal hemodynamic profile and perinatal outcome (birthweight centile) | Perinatal outcome will be evaluated. Birthweight centile will be expressed in centile. | 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. | 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. | 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. | 36 months |
| Correlation between maternal hemodynamic profile and perinatal outcome (major neonatal complications) | Perinatal outcome will be evaluated, such as major neonatal complications. | 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. | 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). | 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. | 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). | 36 months |
| 29899139 | Background | Brown 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. |
| 33771361 | Background | Melchiorre 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. |
| 34774281 | Background | Masini 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. |
| 31254468 | Background | Miremberg 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. |
| 28674092 | Background | Thilaganathan 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. |
| 28424221 | Background | Boyd 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. |
| 26501535 | Background | Auger 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. |
| 26479038 | Background | Brodwall 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. |
| 24159191 | Background | Llurba 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. |
| 12548214 | Background | Taylor 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. |
| 15331514 | Background | Hertig 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. |
| 14764923 | Background | Levine 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. |
| 19375795 | Background | Burton 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. |
| 23746796 | Background | Abalos E, Cuesta C, Grosso AL, Chou D, Say L. Global and regional estimates of preeclampsia and eclampsia: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2013 Sep;170(1):1-7. doi: 10.1016/j.ejogrb.2013.05.005. Epub 2013 Jun 7. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |