ClinicalTrials.gg
CompletedNCT03303768CoAUpdated May 14, 2019

Antenatal Diagnosis of Coarctations of the Aorta.

An observational study in Coarctation of Aorta, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-14.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
Female
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Study summary

Prenatal diagnosis of coarctation is difficult because the ductus arteriosus masks the isthmus narrowing. The problem lies in the fact that it is difficult to assert in utero diagnosis and to predict severity of neonatal symptomatology. However, it is essential to try to establish the diagnosis since it has been shown that the prenatal diagnosis improves survival and reduces morbidity.

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Conditions studied

  • Coarctation of Aorta

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03

In context

Aortic Coarctation

49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.

This study's enrollment of 20 is below the median of 100 across 29 observational studies indexed under Aortic Coarctation.

Browse Aortic Coarctation studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant woman with suspected coarctation of isolated aorta or woman followed in the last 12 for suspected coarctation of the aorta isolated during pregnancy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pregnant or having given birth in the last 12 months in one of the participating centers
  • have had an ultrasound screening in the 2nd or 3rd trimester
  • addressed or being addressed to the Pluridisciplinary Center for Prenatal Diagnosis for suspected coarctation of isolated aorta in front of: ventricular asymmetry at the aegis of the left ventricle or the large vessels at the aorta, discovered during a screening ultrasound second or third quarter.
  • be able to understand and follow the ins and outs of the study
  • Have been informed of the study and have not objected to it

Exclusion criteria

Exclusion Criteria:

  • Associated complex cardiac disease (transposition of large vessels, atrioventricular duct, right ventricle with double outlet) with the exception of inter ventricular communications
  • Left ventricular hypoplasia
  • Suspicion of interruption of the aortic arch
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Pregnant women

    Pregnant woman with suspected coarctation of isolated aorta or woman followed in the last 12 for suspected coarctation of the aorta isolated during pregnancy

    Diagnostic Test: Ultrasound

Interventions

  • Diagnostic testUltrasound

    Investigation of relevant ultrasound signs to improve the antenatal diagnosis of coarctation of the aorta by calculating the sensitivity and specificity of these different signs

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What researchers measure

Primary outcomes

  1. Search for ultrasound risk factors associated with diagnosis coarctation of the aorta

    Calculation of sensitivity, specificity and ROC (Receiver Operating Characteristic) curves of the different ultrasound parameters according to post-natal confirma-diagnosis of coarctation of the aorta in order to create a score to improve the antenatal diagnosis of coarctation the aorta.

    Time frame: 24h after birth

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Study locations

1 site
  • Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant
    Bron, 69677, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in Aug 2018, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2017
First posted
Oct 6, 2017
StartActual
Sep 1, 2017
Primary completionActual
Aug 29, 2018
CompletionActual
Aug 29, 2018
Last update
May 14, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03303768
Responsible party
Sponsor
First posted
Oct 6, 2017
Start date
Sep 1, 2017
Primary completion
Aug 29, 2018
Completion
Aug 29, 2018
Last update
May 14, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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