Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis
NCT ID: NCT04174807
Last Updated: 2021-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2019-12-01
2022-05-01
Brief Summary
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The aim of the current study is to prospectively look for US prenatal features predictive of complicated gastroschisis, on a national multicentric cohort.
Patients will be included during the 22 weeks of amenorrhea (WA) ultrasound examination, and pre- and postnatal clinical data will be recorded up to the 6th months of the child.
Data will then be analysed and compared in the groups of simple or complicated gastroschisis, in order to define pre-natal prognostic factors, to correlate them with specific prognosis, and to might better determine specific strategies for better care of these patients.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Françoise SCHMITT, Dr
Role: PRINCIPAL_INVESTIGATOR
UH Angers
Locations
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University Hospital of Amiens
Amiens, , France
University Hospital of Angers
Angers, , France
University Hospital of Besançon
Besançon, , France
University Hospital of Bordeaux
Bordeaux, , France
University Hospital of Brest
Brest, , France
University Hospital of Caen
Caen, , France
University Hospital of Bicêtre
Clamart, , France
University Hospital of Clermont-Ferrand
Clermont-Ferrand, , France
University Hospital of Dijon
Dijon, , France
University Hospital of Grenoble
Grenoble, , France
University Hospital of Le Havre
Le Havre, , France
University Hospital of Le Mans
Le Mans, , France
University Hospital of Lens
Lens, , France
University Hospital of Lille
Lille, , France
University Hospital of Limoges
Limoges, , France
University Hospital of Lyon
Lyon, , France
University Hospital of Marseille
Marseille, , France
University Hospital of Montpellier
Montpellier, , France
University Hospital of Nancy
Nancy, , France
University Hospital of Nantes
Nantes, , France
University Hospital of Nice
Nice, , France
University Hospital of Nîmes
Nîmes, , France
University Hospital of Orléans
Orléans, , France
University Hospital of Necker
Paris, , France
University Hospital of Robert Debré
Paris, , France
University Hospital of Trousseau
Paris, , France
University Hospital of Poitiers
Poitiers, , France
University Hospital of René Dubos
Pontoise, , France
University Hospital of Reims
Reims, , France
University Hospital of Rennes
Rennes, , France
University Hospital of Rouen
Rouen, , France
University Hospital of Saint-Etienne
Saint-Etienne, , France
University Hospital of Strasbourg
Strasbourg, , France
University Hospital of Toulouse
Toulouse, , France
University Hospital of Tours
Tours, , France
University Hospital of Fort de France
Fort-de-France, , Martinique
Countries
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Central Contacts
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References
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Geslin D, Clermidi P, Gatibelza ME, Boussion F, Saliou AH, Le Manac'h Dove G, Margaryan M, De Vries P, Sentilhes L, Levard G, Lardy H, Arnaud A, Leclair MD, Podevin G, Schmitt F. What prenatal ultrasound features are predictable of complex or vanishing gastroschisis? A retrospective study. Prenat Diagn. 2017 Feb;37(2):168-175. doi: 10.1002/pd.4984. Epub 2017 Jan 25.
Kassa AM, Lilja HE. Predictors of postnatal outcome in neonates with gastroschisis. J Pediatr Surg. 2011 Nov;46(11):2108-14. doi: 10.1016/j.jpedsurg.2011.07.012.
Kuleva M, Khen-Dunlop N, Dumez Y, Ville Y, Salomon LJ. Is complex gastroschisis predictable by prenatal ultrasound? BJOG. 2012 Jan;119(1):102-9. doi: 10.1111/j.1471-0528.2011.03183.x. Epub 2011 Oct 21.
Other Identifiers
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49-RC18-0155
Identifier Type: -
Identifier Source: org_study_id
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