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

Terminated

• Conditions: Pregnancy Related

• Registration Number: NCT03968107
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Study Start: 2019-11-27
• Primary Completion: 2020-12-04
• Study Completion: 2023-01-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 54

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

University Hospital of Montpellier; 🇫🇷 Montpellier, France