Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis

• Conditions: Gastroschisis; Intestinal Occlusion

• Registration Number: NCT04174807
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-22
• Study Start: 2019-12-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-12
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the collar diameter/abdominal circumference ratio as a predictive factor of complex gastroschisis.	2,5 years	The measures of the collar diameter/abdominal circumference ratio on antenatal ultrasound examination will be evaluated as predictive factor of complex gastroschisis

Secondary Outcome Measures

Name	Time	Method
Composite predictive criterion of complex gastroschisis	2,5 years	Define the existence of a composite predictive criterion of complex gastroschisis that incorporates all or several predictive ultrasound factors
Composite predictive criterion of complex gastroschisis by MRI	2,5 years	Perform the same measurements as for outcome 3 by MRI
Evaluation of antenatal ultrasound in predictive diagnosis of complex gastroschisis	2,5 years	Identify other predictive ultrasound factors of complex gastroschisis among the different ultrasound measurements, such as gastric dilatation, maximum diameter of the intraabdominal loop, ...
Measure the impact of complex gastroschisis on follow-up until 6 months of children	6 months of child's life	Use of different parameters (clinical assessment at 6 months, medical history) to evaluate the impact of complex gastroschisis on children at 6 months
Research risk factors in the mother	2,5 years	Search for risk factors for complex gastroschisis from medical examination of the mother (age, tobacco, drugs, body mass index, exposure to chemicals)
Propose a decision algorithm for prenatal management of these patients	2,5 years	Based on identified risk factors

Trial Locations

Locations (36)

University Hospital of Dijon; 🇫🇷 Dijon, France

University Hospital of Besançon; 🇫🇷 Besançon, France

University Hospital of Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

University Hospital of Bicêtre; 🇫🇷 Clamart, France

University Hospital of Angers; 🇫🇷 Angers, France

University Hospital of Le Mans; 🇫🇷 Le Mans, France

University Hospital of Brest; 🇫🇷 Brest, France

University Hospital of Bordeaux; 🇫🇷 Bordeaux, France

University Hospital of Nice; 🇫🇷 Nice, France

University Hospital of Lyon; 🇫🇷 Lyon, France

University Hospital of Nancy; 🇫🇷 Nancy, France

University Hospital of Tours; 🇫🇷 Tours, France

University Hospital of Strasbourg; 🇫🇷 Strasbourg, France

University Hospital of Amiens; 🇫🇷 Amiens, France

University Hospital of Lille; 🇫🇷 Lille, France

University Hospital of Poitiers; 🇫🇷 Poitiers, France

University Hospital of Rennes; 🇫🇷 Rennes, France

University Hospital of Fort de France; 🇲🇶 Fort de France, Martinique

University Hospital of Caen; 🇫🇷 Caen, France

University Hospital of Grenoble; 🇫🇷 Grenoble, France

University Hospital of Le Havre; 🇫🇷 Le Havre, France

University Hospital of Lens; 🇫🇷 Lens, France

University Hospital of Limoges; 🇫🇷 Limoges, France

University Hospital of Marseille; 🇫🇷 Marseille, France

University Hospital of Montpellier; 🇫🇷 Montpellier, France

University Hospital of Nantes; 🇫🇷 Nantes, 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 René Dubos; 🇫🇷 Pontoise, France

University Hospital of Reims; 🇫🇷 Reims, France

University Hospital of Rouen; 🇫🇷 Rouen, France

University Hospital of Saint-Etienne; 🇫🇷 Saint-Étienne, France

University Hospital of Toulouse; 🇫🇷 Toulouse, France