Clinical trial NCT04174807: Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis
Official title: Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroschisis
Intestinal Occlusion
Keywords: gastroschisis
prenatal diagnosis
gastrointestinal complications
wall defect
predictive factors
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-11-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the collar diameter/abdominal circumference ratio as a predictive factor of complex gastroschisis.
timeFrame: 2,5 years
Secondary outcomes:
measure: Evaluation of antenatal ultrasound in predictive diagnosis of complex gastroschisis
timeFrame: 2,5 years
measure: Composite predictive criterion of complex gastroschisis
timeFrame: 2,5 years
measure: Composite predictive criterion of complex gastroschisis by MRI
timeFrame: 2,5 years
measure: Research risk factors in the mother
timeFrame: 2,5 years
measure: Propose a decision algorithm for prenatal management of these patients
timeFrame: 2,5 years
measure: Measure the impact of complex gastroschisis on follow-up until 6 months of children
timeFrame: 6 months of child's life
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital of Amiens
city: Angers
country: France
facility: University Hospital of Angers
city: Besançon
country: France
facility: University Hospital of Besançon
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
city: Brest
country: France
facility: University Hospital of Brest
city: Caen
country: France
facility: University Hospital of Caen
city: Clamart
country: France
facility: University Hospital of Bicêtre
city: Clermont-Ferrand
country: France
facility: University Hospital of Clermont-Ferrand
city: Dijon
country: France
facility: University Hospital of Dijon
city: Grenoble
country: France
facility: University Hospital of Grenoble
city: Le Havre
country: France
facility: University Hospital of Le Havre
city: Le Mans
country: France
facility: University Hospital of Le Mans
city: Lens
country: France
facility: University Hospital of Lens
city: Lille
country: France
facility: University Hospital of Lille
city: Limoges
country: France
facility: University Hospital of Limoges
city: Lyon
country: France
facility: University Hospital of Lyon
city: Marseille
country: France
facility: University Hospital of Marseille
city: Montpellier
country: France
facility: University Hospital of Montpellier
city: Nancy
country: France
facility: University Hospital of Nancy
city: Nantes
country: France
facility: University Hospital of Nantes
city: Nice
country: France
facility: University Hospital of Nice
city: Nîmes
country: France
facility: University Hospital of Nîmes
city: Orléans
country: France
facility: University Hospital of Orléans
city: Paris
country: France
facility: University Hospital of Necker
city: Paris
country: France
facility: University Hospital of Robert Debré
city: Paris
country: France
facility: University Hospital of Trousseau
city: Poitiers
country: France
facility: University Hospital of Poitiers
city: Pontoise
country: France
facility: University Hospital of René Dubos
city: Reims
country: France
facility: University Hospital of Reims
city: Rennes
country: France
facility: University Hospital of Rennes
city: Rouen
country: France
facility: University Hospital of Rouen
city: Saint-Étienne
country: France
facility: University Hospital of Saint-Etienne
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
city: Toulouse
country: France
facility: University Hospital of Toulouse
city: Tours
country: France
facility: University Hospital of Tours
city: Fort de France
country: Martinique
facility: University Hospital of Fort de France
Study officials:
affiliation: UH Angers
name: Françoise SCHMITT, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.