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

Not yet recruiting

• Conditions: Pregnancy; Cardiac Abnormalities; Ultrasound; Fetal Conditions

• Registration Number: NCT05666297
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-18
• Study Start: 2022-12-20
• Study First Submitted QC: 2022-12-23
• Last Update Submitted: 2022-12-23
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27
• Primary Completion: 2023-02-15
• Study Completion: 2023-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 302

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of cardiac abnormalities found in the first trimester of pregnancy	Between 11+0 and 13+6 days of pregnancy	Incidence of cardiac abnormalities found in the first trimester of pregnancy by 3D scan

Secondary Outcome Measures

Name	Time	Method
Gestational age at delivery	delivery	Weeks of gestation at the moment of delivery
Preterm birth rates	Less than 24, 28, 34 weeks gestation
Birth weight	delivery	Weight of the baby at the time of delivery

Trial Locations

Locations (1)

University of Campania "Luigi Vanvitelli"; 🇮🇹 Naples, Italy