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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT03968107
Collaborator
(none)
103
1
60
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Reference ultrasound examination

Study Design

Study Type:
Observational
Anticipated Enrollment :
103 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Diagnostic Performance of Antenatal Ultrasound in the Localization of Intestinal Structures Involved in Malrotation With a Higher-risk of Volvulus
Actual Study Start Date :
Nov 27, 2019
Anticipated Primary Completion Date :
Nov 27, 2024
Anticipated Study Completion Date :
Nov 27, 2024

Arms and Interventions

Arm Intervention/Treatment
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:
  • Fetal MRI
  • Comparison of both results
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT03968107
    Other Study ID Numbers:
    • RECHMPL18_0454 UF 7722
    First Posted:
    May 30, 2019
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 10, 2021