Maternal heart monitoring in pregnancies with fetal heart defects.
Official title: Preeclampsia e Malformazioni Cardiache Fetali: Uno Sguardo al Cuore Materno
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07092644 · Data updated 2026-11-12
This project uses a noninvasive heart monitor on pregnant women carrying a fetus with a congenital heart defect to see if the mother's blood flow and heart measurements are linked to the baby's heart problem and pregnancy outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 108 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | November 16, 2023 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | July 30, 2025 |
| Trial ID | NCT07092644 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with a singleton pregnancy beyond 20 weeks and a prenatal (and postnatal-confirmed) diagnosis of fetal congenital heart disease who can give informed consent and do not have known maternal cardiac disease.
✕Probably not a fit
Patients with multiple pregnancies, fetal aneuploidy or major non-cardiac structural anomalies, or known maternal cardiac disease are excluded and unlikely to benefit from this protocol's specific findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study uses the UltraSonic Cardiac Output Monitor (USCOM®) to record maternal hemodynamic measures—heart rate, blood pressure, stroke volume, cardiac output, and systemic vascular resistance—at diagnosis of fetal congenital heart disease and then every two weeks until delivery, plus once within 72 hours after birth. Investigators will collect maternal demographics, pregnancy labs, serial fetal ultrasound metrics (EFW, UtA-PI, UA-PI, MCA-PI), delivery details, and neonatal outcomes including NICU needs. The aim is to describe maternal hemodynamic profiles in pregnancies with fetal CHD and explore links to specific defect subtypes, development of preeclampsia, and perinatal outcomes. This is a single-center protocol based at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome enrolling consenting adults with singleton pregnancies beyond 20 weeks.
Why it matters
Potential benefit: If successful, the findings could help identify maternal hemodynamic patterns that predict preeclampsia or adverse perinatal outcomes in pregnancies with fetal congenital heart disease, enabling earlier monitoring or targeted management.
How similar studies have gone: Prior studies have linked abnormal maternal hemodynamics to preeclampsia and adverse perinatal outcomes, but serial USCOM monitoring specifically in pregnancies with fetal congenital heart defects is relatively novel and has limited prior evidence.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Francesco Vito 1, 00168, Rome (Italy)
Roma, Italy Recruiting
Study contacts
- Principal investigator: Silvia Salvi — Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome (Italy)
- Study coordinator: Silvia Salvi
- Email: silvia.salvi@policlinicogemelli.it
- Phone: 39 + 3397172786
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.