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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Ultrasound; Fetal Conditions; Cardiac Abnormalities

• Study Type: Observational
• Enrollment (Anticipated): 302

Contacts and Locations

• Study Contact: Name: Antonio Schiattarella, MD; Phone Number: +39 3921653275; Email: antonio.schiattarella@unicampania.it
• Study Contact Backup: Name: Maddalena Morlando, MD,PhD; Email: madmorlando@gmail.com

Study Locations

• Italy
  • Naples, Italy, 80138
    • University of Campania "Luigi Vanvitelli"
    • Contact: Maddalena Morlando, MD; Phone Number: +39 333 426 3110; Email: madmorlando@gmail.com
    • Contact: Fabiana Savoia, MD; Email: dott.fabianasavoia@gmail.com
    • Sub-Investigator: Antonio Schiattarella, MD
    • Sub-Investigator: Anna Conte, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study in question will be conducted prospectively at the structures involved. Participation in the study will be offered to all patients referred to the obstetric ultrasound clinic for the execution of the first trimester ultrasound between 11+0 and 13+6 weeks of gestation, foreseen in normal clinical practice.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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"

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2022
• Primary Completion (Anticipated): February 15, 2023
• Study Completion (Anticipated): May 15, 2023

Study Registration Dates

• First Submitted: December 18, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound; pregnancy; fetal abnormalities; Cardiac Abnormalities
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 37885

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No