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Gastroschisis is a rare congenital malformation consisting in a right para-umbilical defect of the abdominal wall leading to an evisceration of the abdominal content. About 25% of the cases are associated with intestinal malformation, leading to an increase in peri-natal morbidity and mortality. No prospective study has been able to definitely describe predictive factors for complicated gastroschisis on prenatal ultrasound examinations.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the collar diameter/abdominal circumference ratio as a predictive factor of complex gastroschisis. | The measures of the collar diameter/abdominal circumference ratio on antenatal ultrasound examination will be evaluated as predictive factor of complex gastroschisis | 2,5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of antenatal ultrasound in predictive diagnosis of complex gastroschisis | Identify other predictive ultrasound factors of complex gastroschisis among the different ultrasound measurements, such as gastric dilatation, maximum diameter of the intraabdominal loop, ... | 2,5 years |
| Composite predictive criterion of complex gastroschisis |
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Inclusion Criteria:
Every volunteer pregnant woman, in whom an antenatal ultrasound diagnosis of gastroschisis has been carried, before the end of 22 weeks of amenorrhea.
Exclusion Criteria:
Lack of informed consent or refusal of the person to participate in study
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Pregnant women diagnosed with gastroschisis in antenatal and newborns diagnosed with gastroschisis from birth to 6 months of life.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magali FAUCHERE | Contact | +33(0)2 41 35 63 24 | magali.fauchere@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Françoise SCHMITT, Dr | UH Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Amiens | Not yet recruiting | Amiens | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27981591 | Result | 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. | |
| 22075340 |
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Define the existence of a composite predictive criterion of complex gastroschisis that incorporates all or several predictive ultrasound factors |
| 2,5 years |
| Composite predictive criterion of complex gastroschisis by MRI | Perform the same measurements as for outcome 3 by MRI | 2,5 years |
| Research risk factors in the mother | Search for risk factors for complex gastroschisis from medical examination of the mother (age, tobacco, drugs, body mass index, exposure to chemicals) | 2,5 years |
| Propose a decision algorithm for prenatal management of these patients | Based on identified risk factors | 2,5 years |
| Measure the impact of complex gastroschisis on follow-up until 6 months of children | Use of different parameters (clinical assessment at 6 months, medical history) to evaluate the impact of complex gastroschisis on children at 6 months | 6 months of child's life |
| University Hospital of Angers | Recruiting | Angers | France |
|
| University Hospital of Besançon | Recruiting | Besançon | France |
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| University Hospital of Bordeaux | Recruiting | Bordeaux | France |
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| University Hospital of Brest | Recruiting | Brest | France |
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| University Hospital of Caen | Recruiting | Caen | France |
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| University Hospital of Bicêtre | Recruiting | Clamart | France |
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| University Hospital of Clermont-Ferrand | Recruiting | Clermont-Ferrand | France |
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| University Hospital of Dijon | Not yet recruiting | Dijon | France |
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| University Hospital of Grenoble | Recruiting | Grenoble | France |
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| University Hospital of Le Havre | Not yet recruiting | Le Havre | France |
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| University Hospital of Le Mans | Recruiting | Le Mans | France |
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| University Hospital of Lens | Recruiting | Lens | France |
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| University Hospital of Lille | Recruiting | Lille | France |
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| University Hospital of Limoges | Recruiting | Limoges | France |
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| University Hospital of Lyon | Not yet recruiting | Lyon | France |
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| University Hospital of Marseille | Not yet recruiting | Marseille | France |
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| University Hospital of Montpellier | Recruiting | Montpellier | France |
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| University Hospital of Nancy | Recruiting | Nancy | France |
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| University Hospital of Nantes | Recruiting | Nantes | France |
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| University Hospital of Nice | Not yet recruiting | Nice | France |
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| University Hospital of Nîmes | Recruiting | Nîmes | France |
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| University Hospital of Orléans | Recruiting | Orléans | France |
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| University Hospital of Necker | Recruiting | Paris | France |
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| University Hospital of Robert Debré | Recruiting | Paris | France |
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| University Hospital of Trousseau | Recruiting | Paris | France |
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| University Hospital of Poitiers | Recruiting | Poitiers | France |
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| University Hospital of René Dubos | Recruiting | Pontoise | France |
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| University Hospital of Reims | Recruiting | Reims | France |
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| University Hospital of Rennes | Recruiting | Rennes | France |
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| University Hospital of Rouen | Not yet recruiting | Rouen | France |
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| University Hospital of Saint-Etienne | Recruiting | Saint-Etienne | France |
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| University Hospital of Strasbourg | Recruiting | Strasbourg | France |
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| University Hospital of Toulouse | Recruiting | Toulouse | France |
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| University Hospital of Tours | Recruiting | Tours | France |
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| University Hospital of Fort de France | Recruiting | Fort-de-France | Martinique |
|
| 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. |
| 22017923 | Result | 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. |
| ID | Term |
|---|---|
| D020139 | Gastroschisis |
| D007415 | Intestinal Obstruction |
| ID | Term |
|---|---|
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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