Maternal heart monitoring in pregnancies with fetal heart defects.
Preeclampsia e Malformazioni Cardiache Fetali: Uno Sguardo al Cuore Materno
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT07092644 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.