GastroschisisLaparoDANNCT04174807
Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis
An observational study of Gastroschisis and Intestinal Occlusion, run by University Hospital, Angers at 36 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gastroschisis, Intestinal Occlusion
- How many people
- 200 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 1 Dec 2019to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women diagnosed with gastroschisis in antenatal and newborns diagnosed with gastroschisis from birth to 6 months of life.
Who may be able to join
- Every volunteer pregnant woman, in whom an antenatal ultrasound diagnosis of gastroschisis has been carried, before the end of 22 weeks of amenorrhea.
Who cannot join
- Lack of informed consent or refusal of the person to participate in study
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
France35 sites, 35 recruiting
- Not yet recruiting
University Hospital of Amiens
Amiens
Philippe BUISSON, Dr
- Recruiting
University Hospital of Angers
Angers
Françoise SCHMITT, Dr
- Recruiting
University Hospital of Besançon
Besançon
Frédéric AUBER, Pr
- Recruiting
University Hospital of Bordeaux
Bordeaux
Olivier BRISSAUD, Pr
- Recruiting
University Hospital of Brest
Brest
Isabelle GERMOUTY, Dr
- Recruiting
University Hospital of Caen
Caen
Cénéric ALEXANDRE, Dr
- Recruiting
University Hospital of Bicêtre
Clamart
Daniele DE LUCA, Dr
- Recruiting
University Hospital of Clermont-Ferrand
Clermont-Ferrand
Maguelonne PONS, Dr
- Not yet recruiting
University Hospital of Dijon
Dijon
Denis SEMAMA, Dr
- Recruiting
University Hospital of Grenoble
Grenoble
Catherine JACQUIER, Dr
- Not yet recruiting
University Hospital of Le Havre
Le Havre
Stéphane POTEL, Dr
- Recruiting
University Hospital of Le Mans
Le Mans
Audrey ROBINE, Dr
- Recruiting
University Hospital of Lens
Lens
Rony SFEIR, Dr
- Recruiting
University Hospital of Lille
Lille
Rony SFEIR, Dr
- Recruiting
University Hospital of Limoges
Limoges
Julia BALLOUHEY, Dr
- Not yet recruiting
University Hospital of Lyon
Lyon
Thomas GELAS, Dr
- Not yet recruiting
University Hospital of Marseille
Marseille
Anne DARIEL, Dr
- Recruiting
University Hospital of Montpellier
Montpellier
Dominique FORGUES, Dr
- Recruiting
University Hospital of Nancy
Nancy
Nicolas BERTE, Dr
- Recruiting
University Hospital of Nantes
Nantes
Stéphan DE NAPOLI COCCI, Dr
- Not yet recruiting
University Hospital of Nice
Nice
Jean-François LECOMPTE, Dr
- Recruiting
University Hospital of Nîmes
Nîmes
Dominique FORGUES, Dr
- Recruiting
University Hospital of Orléans
Orléans
Marion MARTEAU, Dr
- Recruiting
University Hospital of Necker
Paris
Naziha Khen DUNLOP, Dr
- Recruiting
University Hospital of Robert Debré
Paris
Elisabeth CARRIBABURU, Dr
- Recruiting
University Hospital of Trousseau
Paris
Sabine IRTAN, Dr
- Recruiting
University Hospital of Poitiers
Poitiers
Guillaume LEVARD, Pr
- Recruiting
University Hospital of René Dubos
Pontoise
Jeans-Louis CEOLIN, Dr
- Recruiting
University Hospital of Reims
Reims
Antoine LINE, Dr
- Recruiting
University Hospital of Rennes
Rennes
Alexis ARNAUD, Dr
- Not yet recruiting
University Hospital of Rouen
Rouen
Agnès LIARD, Dr
- Recruiting
University Hospital of Saint-Etienne
Saint-Etienne
Aurélien SCALABRE, Dr
- Recruiting
University Hospital of Strasbourg
Strasbourg
Isabelle TALON, Dr
- Recruiting
University Hospital of Toulouse
Toulouse
Aurélie LE MANDAT, Dr
- Recruiting
University Hospital of Tours
Tours
Thierry VILLEMAGNE, Dr
Martinique1 site, 1 recruiting
- Recruiting
University Hospital of Fort de France
Fort-de-France
Cécilia TOLG, Dr
About this study
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.
Read more
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.
- Conditions
- Gastroschisis, Intestinal Occlusion
- Keywords
- gastroschisis, prenatal diagnosis, gastrointestinal complications, wall defect, predictive factors
- Medical subject headings
- Gastroschisis, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2,5 years
Secondary outcomes (6)
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, ...
Measured: 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
Measured: 2,5 years
Composite predictive criterion of complex gastroschisis by MRI
Perform the same measurements as for outcome 3 by MRI
Measured: 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)
Measured: 2,5 years
Propose a decision algorithm for prenatal management of these patients
Based on identified risk factors
Measured: 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
Measured: 6 months of child's life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Dec 2019
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GastroschisisStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Françoise SCHMITT, Dr, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174807
- Sponsor's protocol ID
- 49-RC18-0155
- Acronym
- LaparoDAN
- Status last verified
- Aug 2021
- First submitted
- 5 Nov 2019
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27981591Kassa 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.
PubMed 22075340Kuleva 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.
PubMed 22017923
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis
- ClinicalTrials.gov ID
- NCT04174807
- Acronym / sponsor ID
- LaparoDAN / 49-RC18-0155
- Conditions
- Gastroschisis, Intestinal Occlusion
- Keywords
- gastroschisis, prenatal diagnosis, gastrointestinal complications, wall defect, predictive factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women diagnosed with gastroschisis in antenatal and newborns diagnosed with gastroschisis from birth to 6 months of life.
Key inclusion criteria (1 listed)
- Every volunteer pregnant woman, in whom an antenatal ultrasound diagnosis of gastroschisis has been carried, before the end of 22 weeks of amenorrhea.
Key exclusion criteria (1 listed)
- Lack of informed consent or refusal of the person to participate in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Evaluation of antenatal ultrasound in predictive diagnosis of complex gastroschisis
Time frame: 2,5 years
Composite predictive criterion of complex gastroschisis
Time frame: 2,5 years
Composite predictive criterion of complex gastroschisis by MRI
Time frame: 2,5 years
Research risk factors in the mother
Time frame: 2,5 years
Propose a decision algorithm for prenatal management of these patients
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Results publication: PubMed 27981591Geslin 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.
- Results publication: PubMed 22075340Kassa 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.
- Results publication: PubMed 22017923Kuleva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise SCHMITT, Dr principal investigator
UH Angers
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroschisis and Intestinal Occlusion, run by University Hospital, Angers at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magali FAUCHERE (+33(0)2 41 35 63 24, magali.fauchere@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the collar diameter/abdominal circumference ratio as a predictive factor of complex gastroschisis. (time frame: 2,5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04174807, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.