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

Sponsor

University of Campania "Luigi Vanvitelli" (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05666297

Collaborator

(none)

302

Enrollment

Location

4.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Ultrasound Fetal Conditions Cardiac Abnormalities

Study Design

Study Type:

Observational

Anticipated Enrollment :

302 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 20, 2022

Anticipated Primary Completion Date :

Feb 15, 2023

Anticipated Study Completion Date :

May 15, 2023

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Campania "Luigi Vanvitelli"	Naples		Italy	80138

Sponsors and Collaborators

University of Campania "Luigi Vanvitelli"

Investigators

Study Chair: Fabiana Savoia, MD, University of Campania "Luigi Vanvitelli"
Principal Investigator: Antonio Schiattarella, MD, University of Campania "Luigi Vanvitelli"