Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis

Conditions
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Gastroschisis, Intestinal Occlusion

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastroschisis, prenatal diagnosis, gastrointestinal complications, wall defect, predictive factors