Prenatal Screening for Congenital Heart Diseases in the Antwerp Region (SEC)

Universiteit Antwerpen

Status: Unknown

Conditions: Congenital Heart Disease in Pregnancy

Treatments: Procedure: prenatal ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT04382222

20/16/205 - 001126

Details and patient eligibility

About

No systematic research has been done in the last 15 years on the accuracy of prenatal ultrasound of congenital heart diseases in Belgium. Nor are there any population-based studies available on this subject for Belgium. Based on the data of EUROCAT (European Surveillance of Congenital Anomalies) the investigators analyse prenatal diagnostic sensitivity of congenital heart diseases in the EUROCAT regions Antwerp (Flanders, Belgium)

Full description

Congenital heart defects are a leading cause of infant mortality with an incidence of 0,4-1,3% at birth. Although prenatal detection rates vary widely, morphological (structural) cardiac malformations are among the most frequently missed abnormalities by prenatal ultrasonography.

However, identifying fetal cardiac abnormalities early in pregnancy is essential. Early diagnosis allows extensive cardiac ultrasound, genetic testing and planning delivery in a paediatric-cardiac centre offering optimal neonatal care.

It also may allow the future parents to consider and decide for a termination of pregnancy in case of a severe fetal heart malformation with poor prognosis.

The investigator conducts a retrospective study on 2500 cases of congenital heart diseases over 20 years. Detailed data for this were made available by the EUROCAT Antwerp registry, a population-based database with controlled, reliable and robust data.

The study wants to reveal the prevalence and prenatal diagnostic sensitivity of congenital heart defects in the EUROCAT regions Antwerp (Flanders) and especially the evolution of the prenatal diagnostic rate over time.

In the second phase, a similar study in two adjacent regions, Hainaut (Wallonia, Belgium) and Groningen (The Netherlands) will follow.

On condition of correct statistic processing, these data will be suitable to compare the prevalence and to benchmark diagnostic rates of congenital heart defects in these three regions.

Enrollment: 2,500 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• All fetal congenital heart diseases registered in the Antwerp-EUROCAT database,
• In the period 1/1/1997-31/12/2017 period

Exclusion criteria

• All cases of congenital heart diseases where the mother was under <18 years old.
• All cases of congenital heart diseases were the parents did not allow inclusion in the EUROCAT registered.
• All cases of congenital heart diseases where the mother delivered outside the EC countries.