MALGRE: Diagnostic Performance of Antenatal Ultrasound in the Localization of Intestinal Structures Involved in Malrotation With a Higher-risk of Volvulus
Study Details
Study Description
Brief Summary
The aims of this study are:
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To assess the performance of third-trimester ultrasound scan in the localization of intestinal structures (small bowel, gut, mesenteric vessels..) involved in malrotations with a higher-risk of volvulus compared to a gold standard based on fetal MRI.
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To describe normal meconium progression (ultrasound and MRI), prenatal anatomical variants of the fetal digestive tract, and interobserver agreement on prenatal ultrasound.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Women with a pregnancy of at least 31 weeks All pregnant women with a pregnancy of at least 31 weeks and having to perform a fetal MRI to identify a cerebral, pulmonary or renal fetal malformation, or due to a diagnostic doubt on ultrasound on an abnormality of these structures, will be proposed inclusion in the study. |
Other: Reference ultrasound examination
Use of antenatal ultrasound examination to visualize and position the intestinal structures involved in digestive malrotation at high risk of volvulus and comparison to fetal MRI results.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut) [At the visit 1 of the subjects]
The primary outcome will be ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut)
Secondary Outcome Measures
- normal meconium progression [At the visit 1 of the subjects]
Normal meconium progression will be described by the results of ultrasound examination and MRI
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pregnant women over the age of 18
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Good understanding of French
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Gestational age greater than or equal than 31 weeks
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Fetal MRI indication validated in multidisciplinary staff at weekly meetings of the Multidisciplinary Prenatal Diagnosis Center in Montpellier or Nimes
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Affiliation or beneficiary of a social security scheme
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Declaration of free and enlightened opposition
Exclusion Criteria:
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Complex fetal abdominal malformations responsible for difficult interpretation of imaging: heterotaxis with asplenia or polysplenium, diaphragmatic hernia, omphalocele, gastroschisis, digestive pathology, abdominal tumor, bladder exstrophy or megavessia.
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Fetal chromosomal abnormality
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Request for termination of pregnancy validated by a Multidisciplinary Pre-natal Diagnosis Center
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University Hospital of Montpellier | Montpellier | France |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
- Principal Investigator: Florent FUCHS, MD, PhD, University Hospital, Montpellier
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RECHMPL18_0454 UF 7722