Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis

NCT04174807 | Unknown

• 1 other identifier: 49-RC18-0155
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 36

Brief Summary

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.

Conditions

Gastroschisis; Intestinal Occlusion

Keywords

gastroschisis; prenatal diagnosis; gastrointestinal complications; wall defect; predictive factors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Evaluation of antenatal ultrasound in predictive diagnosis of complex gastroschisis

  2,5 years

• Composite predictive criterion of complex gastroschisis

  2,5 years

• Composite predictive criterion of complex gastroschisis by MRI

  2,5 years

• Research risk factors in the mother

  2,5 years

• Propose a decision algorithm for prenatal management of these patients

  2,5 years

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women diagnosed with gastroschisis in antenatal and newborns diagnosed with gastroschisis from birth to 6 months of life.

You may qualify if:

• Every volunteer pregnant woman, in whom an antenatal ultrasound diagnosis of gastroschisis has been carried, before the end of 22 weeks of amenorrhea.

You may not qualify if:

• Lack of informed consent or refusal of the person to participate in study

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (36)

University Hospital of Amiens

Amiens, France

NOT YET RECRUITING

University Hospital of Angers

Angers, France

RECRUITING

University Hospital of Besançon

Besançon, France

RECRUITING

University Hospital of Bordeaux

Bordeaux, France

RECRUITING

University Hospital of Brest

Brest, France

RECRUITING

University Hospital of Caen

Caen, France

RECRUITING

University Hospital of Bicêtre

Clamart, France

RECRUITING

University Hospital of Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

University Hospital of Dijon

Dijon, France

NOT YET RECRUITING

University Hospital of Grenoble

Grenoble, France

RECRUITING

University Hospital of Le Havre

Le Havre, France

NOT YET RECRUITING

University Hospital of Le Mans

Le Mans, France

RECRUITING

University Hospital of Lens

Lens, France

RECRUITING

University Hospital of Lille

Lille, France

RECRUITING

University Hospital of Limoges

Limoges, France

RECRUITING

University Hospital of Lyon

Lyon, France

NOT YET RECRUITING

University Hospital of Marseille

Marseille, France

NOT YET RECRUITING

University Hospital of Montpellier

Montpellier, France

RECRUITING

University Hospital of Nancy

Nancy, France

RECRUITING

University Hospital of Nantes

Nantes, France

RECRUITING

University Hospital of Nice

Nice, France

NOT YET RECRUITING

University Hospital of Nîmes

Nîmes, France

RECRUITING

University Hospital of Orléans

Orléans, France

RECRUITING

University Hospital of Necker

Paris, France

RECRUITING

University Hospital of Robert Debré

Paris, France

RECRUITING

University Hospital of Trousseau

Paris, France

RECRUITING

University Hospital of Poitiers

Poitiers, France

RECRUITING

University Hospital of René Dubos

Pontoise, France

RECRUITING

University Hospital of Reims

Reims, France

RECRUITING

University Hospital of Rennes

Rennes, France

RECRUITING

University Hospital of Rouen

Rouen, France

NOT YET RECRUITING

University Hospital of Saint-Etienne

Saint-Etienne, France

RECRUITING

University Hospital of Strasbourg

Strasbourg, France

RECRUITING

University Hospital of Toulouse

Toulouse, France

RECRUITING

University Hospital of Tours

Tours, France

RECRUITING

University Hospital of Fort de France

Fort-de-France, Martinique

RECRUITING

Related Publications (3)

• 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.

  PMID: 27981591 RESULT

• 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.

  PMID: 22075340 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.

  PMID: 22017923 RESULT

MeSH Terms

Conditions

Gastroschisis; Intestinal Obstruction

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Françoise SCHMITT, Dr

  UH Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magali FAUCHERE

CONTACT

+33(0)2 41 35 63 24; magali.fauchere@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 22, 2019
• Study Start: December 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

FR (35); MA (1)