Prenatal Screening for Congenital Heart Diseases in the Antwerp Region

Congenital Heart Disease in Pregnancy Clinical Trial

— SEC  

Official title:

Sensitivity and Accuracy of Prenatal Diagnosis of Severe Congenital Heart Diseases in the Antwerp Region

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04382222
• Other study ID #: 20/16/205 - 001126
• Status: Not yet recruiting
• Start date: June 1, 2020
• Est. completion date: December 2021

Study information

• Verified date: May 2020
• Source: Universiteit Antwerpen
• Contact: Paul Ramaekers, MD
• Phone: +32477772234
• Email: paul.ramaekers1[@]telenet.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: December 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease in Pregnancy
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• prenatal ultrasound
prenatal cardiac ultrasound

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity and accuracy of prenatal ultrasound for cardiac malformations	retrospective analysis of prenatally missed and diagnosed congenital heart disaeses iseaersa	retrospective 20 years