Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis

Gastroschisis Clinical Trial

— LaparoDAN  

Official title:

Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174807
• Other study ID #: 49-RC18-0155
• Status: Recruiting
• Start date: December 1, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2021
• Source: University Hospital, Angers
• Contact: Magali FAUCHERE
• Phone: +33(0)2 41 35 63 24
• Email: magali.fauchere[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroschisis
• Intestinal Obstruction
• Intestinal Occlusion

Locations

Country	Name	City	State
France	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-Étienne
France	University Hospital of Strasbourg	Strasbourg
France	University Hospital of Toulouse	Toulouse
France	University Hospital of Tours	Tours
Martinique	University Hospital of Fort de France	Fort de France

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Countries where clinical trial is conducted

France,  Martinique, 

References & 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 ga — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Composite predictive criterion of complex gastroschisis	Define the existence of a composite predictive criterion of complex gastroschisis that incorporates all or several predictive ultrasound factors	2,5 years
Secondary	Composite predictive criterion of complex gastroschisis by MRI	Perform the same measurements as for outcome 3 by MRI	2,5 years
Secondary	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
Secondary	Propose a decision algorithm for prenatal management of these patients	Based on identified risk factors	2,5 years
Secondary	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