NCT07092644Recruiting
Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart
Preeclampsia e Malformazioni Cardiache Fetali: Uno Sguardo al Cuore Materno
Source: ClinicalTrials.gov · Last updated 30 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 30 Jun 2025
- Start date
- 16 Nov 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- NCT number
- NCT07092644
What you commit to
- Study type: Interventional
- Planned participants: 108
- From 16 Nov 2023 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pregnancy complicated by aneuploidy, genetic syndrome, or major structural fetal abnormality
- Maternal congenital heart disease (GUCH)
- Maternal known cardiac disease
Other
- Multiple pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy) Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.