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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT03356314

Collaborator

(none)

9,000

Enrollment

Location

Actual Duration (Months)

820.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Malrotation	Other: MRI between 30-35 GA Other: Pediatric surgeon meeting Other: Postnatal abdominal ultrasound, barium enema and upper gastrointestinal Other: +/- prophylactic surgery

Study Design

Study Type:

Observational

Actual Enrollment :

9000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Prenatal Ultrasound Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of The Relative Position of The Superior Mesenteric Artery and Vein. Future of the Children With an Antenatal Malrotation Suspicion

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Outcome Measures

Primary Outcome Measures

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

Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition. [1 day (During Pregnancy)]
Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.
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.