Prenatal Ultrasound Screening of Intestinal Malrotation With a Higher Risk of Volvulus

Completed

• Conditions: Intestinal Malrotation

• Registration Number: NCT03356314
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The aim of this study was to assess the value of an unusual relative position of the superior mesenteric artery (SMA) and vein (SMV) to screen intestinal malrotation with a higher risk of volvulus.

First, feasibility study was done to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.

A systematic screening of the mesenteric vessels position was performed at each pregnancy required ultrasound.

When the fœtus had an unusual position of the mesenteric vessels, an MRI was suggested between 30 and 35 GA and the couple met the pediatric surgery team.

Few days after birth, an abdominal ultrasound was achieved as well as a barium enema and upper gastrointestinal. If there were a hight probability of malrotation with a higher risk of volvulus, a prophylactic surgery was proposed. The children were flollowed up during 1 year.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-05-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-11-29
• Study Completion: 2017-12-01
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reproducibility of ultrasound in the diagnosis of the abnormal position of the mesenteric vessels	1 day (Pre and post natal ultrasound)	Feasibility study to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.
Antenatal screening of intestinal malrotation	1 day (Pre and post natal ultrasound)	Antenatal screening of intestinal malrotation with higher risk of volvulus.
Future of the children with an ante natal diagnosis of intestinal malrotation	1 year after birth	Future of the children with an ante natal diagnosis of intestinal malrotation

Secondary Outcome Measures

Name	Time	Method
Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.	1 day (after delivery)	Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France