Diagnostic Performance of Antenatal Ultrasound in the Localization of Intestinal Structures Involved in Malrotation With a Higher-risk of Volvulus

Overview

The aims of this study are: – 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. – To describe normal meconium progression (ultrasound and MRI), prenatal anatomical variants of the fetal digestive tract, and interobserver agreement on prenatal ultrasound.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 27, 2024

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut)
    • Time Frame: At the visit 1 of the subjects
    • The primary outcome will be ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut)

Secondary Measures

  • normal meconium progression
    • Time Frame: At the visit 1 of the subjects
    • Normal meconium progression will be described by the results of ultrasound examination and MRI

Participating in This Clinical Trial

Inclusion Criteria

  • Pregnant women over the age of 18 – Good understanding of French – Gestational age greater than or equal than 31 weeks – Fetal MRI indication validated in multidisciplinary staff at weekly meetings of the Multidisciplinary Prenatal Diagnosis Center in Montpellier or Nimes – Affiliation or beneficiary of a social security scheme – Declaration of free and enlightened opposition Exclusion Criteria:

  • 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. – Fetal chromosomal abnormality – Request for termination of pregnancy validated by a Multidisciplinary Pre-natal Diagnosis Center

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Florent FUCHS, MD, PhD, Principal Investigator, University Hospital, Montpellier
  • Overall Contact(s)
    • Florent FUCHS, MD, PhD, 06 65 84 94 80, f-fuchs@chu-montpellier.fr

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