Congenital Heart Disease in PregnancySECNCT04382222
Prenatal Screening for Congenital Heart Diseases in the Antwerp Region
An observational study of Congenital Heart Disease in Pregnancy, run by Universiteit Antwerpen at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Congenital Heart Disease in Pregnancy
- What is being tested?
- prenatal ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 2,500 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Low risk pregnancies
Who may be able to join
- All fetal congenital heart diseases registered in the Antwerp-EUROCAT database,
- In the period 1/1/1997-31/12/2017 period
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Yves Jacquemyn, PhD contact
About this study
Official title: 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)
Read the 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.
- Conditions
- Congenital Heart Disease in Pregnancy
- Being tested
- prenatal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prenatal ultrasoundProcedure or surgery
prenatal cardiac ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and accuracy of prenatal ultrasound for cardiac malformations
retrospective analysis of prenatally missed and diagnosed congenital heart disaeses iseaersa
Measured: retrospective 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Yves Jacquemyn, Universiteit Antwerpen
- Investigators
- Paul Ramaekers, MD, Study chair, University AntwerpenYves Jacquemyn, Study chair, University Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382222
- Sponsor's protocol ID
- 20/16/205 - 001126
- Acronym
- SEC
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Accuracy of Prenatal Diagnosis of Severe Congenital Heart Diseases in the Antwerp Region
- ClinicalTrials.gov ID
- NCT04382222
- Acronym / sponsor ID
- SEC / 20/16/205 - 001126
- Conditions
- Congenital Heart Disease in Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Low risk pregnancies
Key inclusion criteria (2 listed)
- All fetal congenital heart diseases registered in the Antwerp-EUROCAT database,
- In the period 1/1/1997-31/12/2017 period
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prenatal ultrasoundprenatal cardiac ultrasound | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Jacquemyn, PhD contact
Paul Ramaekers, MD study chair
University Antwerpen
Yves Jacquemyn study chair
University Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease in Pregnancy, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Ramaekers, MD (+32477772234, paul.ramaekers1@telenet.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and accuracy of prenatal ultrasound for cardiac malformations (time frame: retrospective 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.