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

Pregnancy Related Clinical Trial

— MALGRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968107
• Other study ID #: RECHMPL18_0454 UF 7722
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Intestinal Volvulus
• Pregnancy Related

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