Clinical trial NCT04382222: Prenatal Screening for Congenital Heart Diseases in the Antwerp Region
Official title: Sensitivity and Accuracy of Prenatal Diagnosis of Severe Congenital Heart Diseases in the Antwerp Region
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease in Pregnancy
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low risk pregnancies

Brief summary: 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)

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: sensitivity and accuracy of prenatal ultrasound for cardiac malformations
timeFrame: retrospective 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Antwerpen
name: Paul Ramaekers, MD
role: STUDY_CHAIR
affiliation: University Antwerpen
name: Yves Jacquemyn
role: STUDY_CHAIR
References: