Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart

NCT07092644 | Recruiting

• 2 other identifiers: 7552Ethic Committee Gemelli
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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).

Conditions

Congenital Heart Disease

Keywords

Preeclampsia; Congenital Heart Disease; Maternal Hemodynamic

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (14)

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

  36 months

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

  36 months

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

  36 months

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

  36 months

• Correlation between maternal hemodynamic profile and perinatal outcome (birthweight)

  36 months

Study Arms (1)

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.

Device: UltraSonic Cardiac Output Monitor (USCOM®)

Interventions

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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Multiple pregnancy
• Pregnancy complicated by aneuploidy, genetic syndrome, or major structural fetal abnormality
• Maternal congenital heart disease (GUCH)
• Maternal known cardiac disease

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

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

Roma, 00168, Italy

RECRUITING

Related Publications (16)

• 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.

  PMID: 26970353 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.

  PMID: 28979476 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.

  PMID: 29899139 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.

  PMID: 33771361 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.

  PMID: 34774281 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.

  PMID: 31254468 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.

  PMID: 28674092 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.

  PMID: 28424221 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.

  PMID: 26501535 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.

  PMID: 26479038 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.

  PMID: 24159191 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.

  PMID: 12548214 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.

  PMID: 15331514 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.

  PMID: 14764923 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.

  PMID: 19375795 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.

  PMID: 23746796 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Silvia Salvi

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome (Italy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Salvi

CONTACT

39 + 3397172786; silvia.salvi@policlinicogemelli.it

Federica Totaro Aprile

CONTACT

39 + 3347347894; federica.totaroaprile01@icatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor Specialised in Obstetrics and Gyanecology

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 30, 2025
• Study Start: November 16, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)