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

NCT05666297 | Unknown DMC

• 1 other identifier: 37885
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Ultrasound; Fetal Conditions; Cardiac Abnormalities

Keywords

pregnancy; ultrasound; fetal abnormalities; Cardiac Abnormalities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gestational age at delivery

  delivery

• Preterm birth rates

  Less than 24, 28, 34 weeks gestation

• Birth weight

  delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients referred to the obstetric ultrasound clinic for the execution of the first trimester ultrasound between 11+0 and 13+6 weeks of gestation

You may not qualify if:

• Less than 18 years old
• Multiple gestations
• Women with an altered state of consciousness, seriously ill, with mental handicaps;

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania "Luigi Vanvitelli"

Naples, 80138, Italy

Location

Study Officials

• Fabiana Savoia, MD

  University of Campania Luigi Vanvitelli

  STUDY CHAIR

• Antonio Schiattarella, MD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Schiattarella, MD

CONTACT

+39 3921653275; antonio.schiattarella@unicampania.it

Maddalena Morlando, MD,PhD

CONTACT

madmorlando@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: December 27, 2022
• Study Start: December 20, 2022
• Primary Completion: February 15, 2023
• Study Completion: May 15, 2023
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

IT (1)