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

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ClinicalTrials.gov Identifier: NCT03968107
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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
Pregnancy Related Other: Reference ultrasound examination

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Study Type : Observational
Estimated Enrollment : 264 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 : November 27, 2019
Estimated Primary Completion Date : November 27, 2021
Estimated Study Completion Date : November 27, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Women with a singleton pregnancy over 28 weeks
All pregnant women with a singleton pregnancy over 28 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women with normal intestinal structure and requiring a fetal MRI for other reason
Criteria

Inclusion Criteria:

  • Pregnant women over the age of 18
  • Good understanding of French
  • Single pregnancy
  • Gestational age greater than 28 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
  • Body mass index of mother> 40kg / m2 in early pregnancy
  • Request for termination of pregnancy validated by a Multidisciplinary Pre-natal Diagnosis Center

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968107


Contacts
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Contact: Florent FUCHS, PhD 06 65 84 94 80 f-fuchs@chu-montpellier.fr

Locations
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France
University Hospital of Montpellier Recruiting
Montpellier, France
Contact: Florent FUCHS       f-fuchs@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Florent FUCHS, PhD University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03968107    
Other Study ID Numbers: RECHMPL18_0454 UF 7722
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
malrotation
intestinal structures
mesenteric vessels
Additional relevant MeSH terms:
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Intestinal Volvulus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Torsion Abnormality
Pathological Conditions, Anatomical