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Clinical Trials/NCT05666297
NCT05666297
Not yet recruiting
Not Applicable

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

University of Campania "Luigi Vanvitelli"1 site in 1 country302 target enrollmentDecember 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
University of Campania "Luigi Vanvitelli"
Enrollment
302
Locations
1
Primary Endpoint
Incidence of cardiac abnormalities found in the first trimester of pregnancy
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 20, 2022
End Date
May 15, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Antonio Schiattarella

MD

University of Campania "Luigi Vanvitelli"

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Incidence of cardiac abnormalities found in the first trimester of pregnancy

Time Frame: Between 11+0 and 13+6 days of pregnancy

Incidence of cardiac abnormalities found in the first trimester of pregnancy by 3D scan

Secondary Outcomes

  • Gestational age at delivery(delivery)
  • Preterm birth rates(Less than 24, 28, 34 weeks gestation)
  • Birth weight(delivery)

Study Sites (1)

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