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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03968107
Other study ID # RECHMPL18_0454 UF 7722
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 27, 2019
Est. completion date November 27, 2024

Study information

Verified date March 2023
Source University Hospital, Montpellier
Contact Florent FUCHS, MD, PhD
Phone 06 65 84 94 80
Email f-fuchs@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 103
Est. completion date November 27, 2024
Est. primary completion date November 27, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France University Hospital of Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut) The primary outcome will be ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut) At the visit 1 of the subjects
Secondary normal meconium progression Normal meconium progression will be described by the results of ultrasound examination and MRI At the visit 1 of the subjects
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