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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05666297
• Other study ID #: 37885
• Status: Not yet recruiting
• Start date: December 20, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: December 2022
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Antonio Schiattarella, MD
• Phone: +39 3921653275
• Email: antonio.schiattarella[@]unicampania.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 302
• Est. completion date: May 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Congenital Abnormalities
• Fetal Conditions
• Pregnancy
• Ultrasound

Locations

Country	Name	City	State
Italy	University of Campania "Luigi Vanvitelli"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiac abnormalities found in the first trimester of pregnancy	Incidence of cardiac abnormalities found in the first trimester of pregnancy by 3D scan	Between 11+0 and 13+6 days of pregnancy
Secondary	Gestational age at delivery	Weeks of gestation at the moment of delivery	delivery
Secondary	Preterm birth rates		Less than 24, 28, 34 weeks gestation
Secondary	Birth weight	Weight of the baby at the time of delivery	delivery