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Screening of Cardiac Abnormalities in the First Trimester of Pregnancy by Volumetric Acquisition

Screening of Cardiac Abnormalities in the First Trimester of Pregnancy by Volumetric Acquisition: an International Multicenter Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05666297
Enrollment
302
Registered
2022-12-27
Start date
2022-12-20
Completion date
2023-05-15
Last updated
2022-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Abnormalities, Fetal Conditions, Pregnancy, Ultrasound

Keywords

pregnancy, ultrasound, fetal abnormalities, Cardiac Abnormalities

Brief summary

Ultrasound is one of the most important tools in pregnancy both for its diagnostic capacity, but also because it is not invasive. For physiological pregnancy, the Italian guidelines provide for the execution of 3 ultrasounds: one in the first trimester (between 11 and 14 weeks), one in the second trimester (between 20 and 22 weeks) and one in the third (between 30 and 36 weeks). weeks). Screening for cardiac abnormalities is done during second trimester ultrasound, also called structural ultrasound. However, the development of three-dimensional (3D) sonography has represented a dramatic shift in obstetrics as it allows for the acquisition of a volume of data rather than conventional planar or 2D scans. This method has allowed considerable progress in the study of the fetus in the initial stages of development and has opened new windows in the knowledge of anatomical malformations at an early age. The possibility of detecting structural anomalies already during the first trimester of pregnancy allows, in fact, to provide the patient with additional time for counseling and for any genetic tests.

Interventions

None listed

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients referred to the obstetric ultrasound clinic for the execution of the first trimester ultrasound between 11+0 and 13+6 weeks of gestation

Exclusion criteria

* Less than 18 years old * Multiple gestations * Women with an altered state of consciousness, seriously ill, with mental handicaps;

Design outcomes

Primary

MeasureTime frameDescription
Incidence of cardiac abnormalities found in the first trimester of pregnancyBetween 11+0 and 13+6 days of pregnancyIncidence of cardiac abnormalities found in the first trimester of pregnancy by 3D scan

Secondary

MeasureTime frameDescription
Gestational age at deliverydeliveryWeeks of gestation at the moment of delivery
Preterm birth ratesLess than 24, 28, 34 weeks gestation
Birth weightdeliveryWeight of the baby at the time of delivery

Countries

Italy

Contacts

Primary ContactAntonio Schiattarella, MD
antonio.schiattarella@unicampania.it+39 3921653275
Backup ContactMaddalena Morlando, MD,PhD
madmorlando@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026