Clinical trial NCT05666297: Screening of Cardiac Abnormalities in the First Trimester of Pregnancy by Volumetric Acquisition
Official title: Screening of Cardiac Abnormalities in the First Trimester of Pregnancy by Volumetric Acquisition: an International Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Ultrasound
Fetal Conditions
Cardiac Abnormalities
Keywords: pregnancy
ultrasound
fetal abnormalities
Cardiac Abnormalities
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 302
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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;

Primary outcomes:
measure: Incidence of cardiac abnormalities found in the first trimester of pregnancy
timeFrame: Between 11+0 and 13+6 days of pregnancy
Secondary outcomes:
measure: Gestational age at delivery
timeFrame: delivery
measure: Preterm birth rates
timeFrame: Less than 24, 28, 34 weeks gestation
measure: Birth weight
timeFrame: delivery
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania "Luigi Vanvitelli"
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Fabiana Savoia, MD
role: STUDY_CHAIR
affiliation: University of Campania Luigi Vanvitelli
name: Antonio Schiattarella, MD
role: PRINCIPAL_INVESTIGATOR
References: