Prenatal Screening for Congenital Heart Diseases in the A... | NCT04382222

Studies
Prenatal Screening for Congenital Heart Diseases in the Antwerp Region

NCT04382222

Sponsor

Universiteit Antwerpen

Status

Unknown status

Last Update Posted

May 18, 2020Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Congenital Heart Disease in Pregnancy

Interventions

prenatal ultrasound

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Estimated

Primary Completion Date

May 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

May 6, 2020

First Submission Date that Met QC Criteria

May 8, 2020

First Posted Date

May 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2020

Last Update Posted Date

May 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof Yves Jacquemyn, Professor, Universiteit AntwerpenPrincipal Investigator

Lead Sponsor

Universiteit AntwerpenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
prenatal ultrasound	Procedure	prenatal cardiac ultrasound

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Low risk pregnancies

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paul Ramaekers, MD	Contact	+32477772234		paul.ramaekers1@telenet.be
Yves Jacquemyn, PhD	Contact	+3238215945

Overall Officials

Name	Affiliation	Role
Paul Ramaekers, MD	University Antwerpen	Study Chair
Yves Jacquemyn	University Antwerpen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Antwerp		Edegem	Antwerp	2650	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided