NCT07092644 Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart
| NCT ID | NCT07092644 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2023-11-16 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2023-11-16 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Multiple pregnancy * Pregnancy complicated by aneuploidy, genetic syndrome, or major structural fetal abnormality * Maternal congenital heart disease (GUCH) * Maternal known cardiac disease
Contact & Investigator
Silvia Salvi
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome (Italy)
Frequently Asked Questions
Who can join the NCT07092644 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07092644 currently recruiting?
Yes, NCT07092644 is actively recruiting participants. Contact the research team at silvia.salvi@policlinicogemelli.it for enrollment information.
Where is the NCT07092644 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07092644 clinical trial?
NCT07092644 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Silvia Salvi at Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome (Italy). The trial plans to enroll 108 participants.