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

May 14, 2020 updated by: Prof Yves Jacquemyn, Universiteit Antwerpen

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

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • University Hospital Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Low risk pregnancies

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity and accuracy of prenatal ultrasound for cardiac malformations
Time Frame: retrospective 20 years
retrospective analysis of prenatally missed and diagnosed congenital heart disaeses iseaersa
retrospective 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Investigators

  • Study Chair: Paul Ramaekers, MD, University Antwerpen
  • Study Chair: Yves Jacquemyn, University Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/16/205 - 001126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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