NCT04382222

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

May 6, 2020

Last Update Submit

May 14, 2020

Conditions

Congenital Heart Disease in Pregnancy

Outcome Measures

Primary Outcomes (1)

  • sensitivity and accuracy of prenatal ultrasound for cardiac malformations

    retrospective analysis of prenatally missed and diagnosed congenital heart disaeses iseaersa

    retrospective 20 years

Interventions

prenatal ultrasoundPROCEDURE

prenatal cardiac ultrasound

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Low risk pregnancies

You may qualify if:

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

You may not qualify if:

  • All cases of congenital heart diseases where the mother was under \<18 years old.
  • All cases of congenital heart diseases where the mother delivered outside the EC countries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Study Officials

  • Paul Ramaekers, MD

    University Antwerpen

    STUDY CHAIR

  • Yves Jacquemyn

    University Antwerpen

    STUDY CHAIR

Central Study Contacts

Paul Ramaekers, MD

CONTACT

+32477772234paul.ramaekers1@telenet.be

Yves Jacquemyn, PhD

CONTACT

+3238215945

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 11, 2020

Study Start

June 1, 2020

Primary Completion

May 1, 2021

Study Completion

December 1, 2021

Last Updated

May 18, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)