Screening of Cardiac Abnormalities in the First Trimester of Pregnancy by Volumetric Acquisition: an International Multicenter Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- University of Campania "Luigi Vanvitelli"
- Enrollment
- 302
- Locations
- 1
- Primary Endpoint
- Incidence of cardiac abnormalities found in the first trimester of pregnancy
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Antonio Schiattarella
MD
University of Campania "Luigi Vanvitelli"
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;
Outcomes
Primary Outcomes
Incidence of cardiac abnormalities found in the first trimester of pregnancy
Time Frame: Between 11+0 and 13+6 days of pregnancy
Incidence of cardiac abnormalities found in the first trimester of pregnancy by 3D scan
Secondary Outcomes
- Gestational age at delivery(delivery)
- Preterm birth rates(Less than 24, 28, 34 weeks gestation)
- Birth weight(delivery)