Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis (LaparoDAN)

August 5, 2021 updated by: University Hospital, Angers

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • University Hospital of Amiens
        • Principal Investigator:
          • Philippe BUISSON, Dr
      • Angers, France
        • Recruiting
        • University Hospital of Angers
        • Principal Investigator:
          • Françoise SCHMITT, Dr
      • Besançon, France
        • Recruiting
        • University Hospital of Besancon
        • Principal Investigator:
          • Frédéric AUBER, Pr
      • Bordeaux, France
        • Recruiting
        • University Hospital of Bordeaux
        • Principal Investigator:
          • Olivier BRISSAUD, Pr
      • Brest, France
        • Recruiting
        • University Hospital of Brest
        • Principal Investigator:
          • Isabelle GERMOUTY, Dr
      • Caen, France
        • Recruiting
        • University Hospital of Caen
        • Principal Investigator:
          • Cénéric ALEXANDRE, Dr
      • Clamart, France
        • Recruiting
        • University hospital of Bicêtre
        • Principal Investigator:
          • Daniele DE LUCA, Dr
      • Clermont-Ferrand, France
        • Recruiting
        • University Hospital of Clermont-Ferrand
        • Principal Investigator:
          • Maguelonne PONS, Dr
      • Dijon, France
        • Not yet recruiting
        • University Hospital of Dijon
        • Principal Investigator:
          • Denis SEMAMA, Dr
      • Grenoble, France
        • Recruiting
        • University hospital of Grenoble
        • Principal Investigator:
          • Catherine JACQUIER, Dr
      • Le Havre, France
        • Not yet recruiting
        • University Hospital of Le Havre
        • Principal Investigator:
          • Stéphane POTEL, Dr
      • Le Mans, France
        • Recruiting
        • University Hospital of Le Mans
        • Principal Investigator:
          • Audrey ROBINE, Dr
      • Lens, France
        • Recruiting
        • University Hospital of Lens
        • Principal Investigator:
          • Rony SFEIR, Dr
      • Lille, France
        • Recruiting
        • University Hospital of Lille
        • Principal Investigator:
          • Rony SFEIR, Dr
      • Limoges, France
        • Recruiting
        • University Hospital of Limoges
        • Principal Investigator:
          • Julia BALLOUHEY, Dr
      • Lyon, France
        • Not yet recruiting
        • University Hospital of Lyon
        • Principal Investigator:
          • Thomas GELAS, Dr
      • Marseille, France
        • Not yet recruiting
        • University Hospital of Marseille
        • Principal Investigator:
          • Anne DARIEL, Dr
      • Montpellier, France
        • Recruiting
        • University Hospital of Montpellier
        • Principal Investigator:
          • Dominique FORGUES, Dr
      • Nancy, France
        • Recruiting
        • University Hospital Of Nancy
        • Principal Investigator:
          • Nicolas BERTE, Dr
      • Nantes, France
        • Recruiting
        • University Hospital of Nantes
        • Principal Investigator:
          • Stéphan DE NAPOLI COCCI, Dr
      • Nice, France
        • Not yet recruiting
        • University Hospital of Nice
        • Principal Investigator:
          • Jean-François LECOMPTE, Dr
      • Nîmes, France
        • Recruiting
        • University Hospital of Nîmes
        • Principal Investigator:
          • Dominique FORGUES, Dr
      • Orléans, France
        • Recruiting
        • University Hospital of Orléans
        • Principal Investigator:
          • Marion MARTEAU, Dr
      • Paris, France
        • Recruiting
        • University Hospital of Necker
        • Principal Investigator:
          • Naziha Khen DUNLOP, Dr
      • Paris, France
        • Recruiting
        • University Hospital of Trousseau
        • Principal Investigator:
          • Sabine IRTAN, Dr
      • Paris, France
        • Recruiting
        • University Hospital of Robert Debré
        • Principal Investigator:
          • Elisabeth CARRIBABURU, Dr
      • Poitiers, France
        • Recruiting
        • University Hospital of Poitiers
        • Principal Investigator:
          • Guillaume LEVARD, Pr
      • Pontoise, France
        • Recruiting
        • University Hospital of René Dubos
        • Principal Investigator:
          • Jeans-Louis CEOLIN, Dr
      • Reims, France
        • Recruiting
        • University Hospital of Reims
        • Principal Investigator:
          • Antoine LINE, Dr
      • Rennes, France
        • Recruiting
        • University Hospital of Rennes
        • Principal Investigator:
          • Alexis ARNAUD, Dr
      • Rouen, France
        • Not yet recruiting
        • University Hospital of Rouen
        • Principal Investigator:
          • Agnès LIARD, Dr
      • Saint-Étienne, France
        • Recruiting
        • University Hospital of Saint-Etienne
        • Principal Investigator:
          • Aurélien SCALABRE, Dr
      • Strasbourg, France
        • Recruiting
        • University Hospital of Strasbourg
        • Principal Investigator:
          • Isabelle TALON, Dr
      • Toulouse, France
        • Recruiting
        • University Hospital of Toulouse
        • Principal Investigator:
          • Aurélie LE MANDAT, Dr
      • Tours, France
        • Recruiting
        • University Hospital of Tours
        • Principal Investigator:
          • Thierry VILLEMAGNE, Dr
  • Martinique
      • Fort de France, Martinique
        • Recruiting
        • University Hospital of Fort de France
        • Principal Investigator:
          • Cécilia TOLG, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the collar diameter/abdominal circumference ratio as a predictive factor of complex gastroschisis.
Time Frame: 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
2,5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of antenatal ultrasound in predictive diagnosis of complex gastroschisis
Time Frame: 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, ...
2,5 years
Composite predictive criterion of complex gastroschisis
Time Frame: 2,5 years
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
Time Frame: 2,5 years
Perform the same measurements as for outcome 3 by MRI
2,5 years
Research risk factors in the mother
Time Frame: 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)
2,5 years
Propose a decision algorithm for prenatal management of these patients
Time Frame: 2,5 years
Based on identified risk factors
2,5 years
Measure the impact of complex gastroschisis on follow-up until 6 months of children
Time Frame: 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
6 months of child's life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Françoise SCHMITT, Dr, UH Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 12, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49-RC18-0155

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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