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Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart

NCT07092644 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-07-30

No results posted yet for this study

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).

Conditions

  • Congenital Heart Disease

Interventions

DEVICE

UltraSonic Cardiac Output Monitor (USCOM®)

Using USCOM, the haemodynamic evaluation will be performed at the time of diagnosis of congenital heart desease and then every two weeks until delivery. A further evaluation will be performed immediately after delivery (within 72 hours).

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Silvia Salvi · Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome (Italy)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07092644 on ClinicalTrials.gov