
1-overview-of-the-study.pdf
136.36 kB
DownloadIn a proportion of fetuses with aortic valve stenosis the cardiac defect will evolve into hypoplastic left heart syndrome (HLHS) before birth. Fetal aortic valvuloplasty has been suggested as a method to prevent evolution into HLHS but the level of evidence in previous studies is low. To address the shortcomings of previous studies we are undertaking an international prospective observational cohort study with a comparison cohort.
If you are interested in joining this study please send an email to Annika Öhman and to Mats Mellander:
These are identical in the intervention and non-intervention groups:
LINK: Inclusion criteria >
LINK: Exclusion criteria >
Echo data are uniformly obtained according to the following instructions:
Collection of clinical data and echocardiographic measurements will be through electronic Case Report Forms (eCRF) to an online database (MediCase).
MediCase database – instructions for user >
MediCase eCRF - company and system security >
Annotated eCRF (all variables in MediCase database in detail) >
MediCase I – How to begin – inclusion and baseline fetal echo MediCase
MediCase II – Additional forms
MediCase III – Neonatal forms
MediCase IV – 2- years follow-up
Echocardiographic exams will be uploaded to a core laboratory FTPS server managed by the University of Gothenburg.
Core lab – instructions for user >
Quick guide to Core lab FTPS server >
Core lab FTPS server security >
How to anonymize an exam in Voluson >
FTPS server – How to upload echoes:
Data analysis and statistical analysis plan (SAP) >
Co-authorship will be based on the criteria published by ICMJE.
ICMJE statement on co-authorship >
The steering group has at least one member from each country.
LINK: Steering group members
1-overview-of-the-study.pdf
136.36 kB
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2-short-instruction-for-new-local-investigators.pdf
66.56 kB
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3-fassprosp-research-program-version-2022-02-21.pdf
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4-consent-form-in-english.pdf
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5-medicase-ecrf-company-and-system-security.pdf
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6-core-lab-server-security.pdf
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7-core-lab-instructions-for-user.pdf
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8-medicase-instructions-for-user.pdf
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9-quick-guide-to-core-lab-ftps-server-and-medicase.pdf
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10-how-to-anonymize-an-exam-in-voluson-us-2.pdf
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11-manual-of-fetal-echo.pdf
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12-manual-of-postnatal-echo.pdf
7 MB
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13-fassprosp-annotated-crf-version-18.pdf
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14-statistical-analysis-plan-sap-final-20210318.pdf
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