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

Recruiting

• Conditions: Pregnancy Related
• Interventions: Other: Reference ultrasound examination

• 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
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-13
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 103

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

Arm && Interventions

Group	Intervention	Description
Women with a pregnancy of at least 31 weeks	Reference ultrasound examination	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.

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