Measures heart output in pregnant women carrying a fetus with a heart defect
Studies heart blood flow measured in pregnant adults whose unborn baby has a heart defect.
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Roma, ItalySee the site
- Trial code
- Registry title
- Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart
- Status
- Recruiting
- People taking part
- 108 people, planned
- Started
- 16 Nov 2023
- Expected to end
- Nov 2026
- Type of study
- Interventional
- Treatments tested
- UltraSonic Cardiac Output Monitor (USCOM®)
- Record updated
- 30 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adult women pregnant with one baby who has a congenital heart disease. Heart blood-flow measurements are taken during pregnancy and after birth.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Pregnant with one baby, beyond 20 weeks of pregnancy, whose heart disease was seen on ultrasound before birth and confirmed after birth.
Main reasons for not taking part
- Pregnant with more than one baby
- Baby with a chromosome change, genetic syndrome or major structural abnormality
- Mother has a congenital heart disease
- Mother has a known heart disease
This trial only enrols pregnant participants. The registry sentence this rests on: 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
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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 take part
- Pregnancy complicated by aneuploidy, genetic syndrome, or major structural fetal abnormality
- Maternal congenital heart disease (GUCH)
- Maternal known cardiac disease
- Multiple pregnancy
Where in Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy)Roma, ItalyContact: Silvia SalviTaking people
About the trial
What the trial wants to find out
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 full original descriptionShow less
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).
The group in the trial
- Hemodynamic evaluation in pregnant women carring a fetus with a congenital heart deseaseOther group
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.
Treatment: UltraSonic Cardiac Output Monitor (USCOM®)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Preeclampsia e Malformazioni Cardiache Fetali: Uno Sguardo al Cuore Materno
- Plain-language title
- Measures heart output in pregnant women carrying a fetus with a heart defectGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 30 July 2025