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

Intestinal Malrotation Clinical Trial

— VOLMES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356314
• Other study ID #: RECHMPL17_0258
• Status: Completed
• First received: October 12, 2017
• Last updated: April 23, 2018
• Start date: January 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9000
• Est. completion date: December 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• pregnant women

• second or third trimester ultrasound.

Exclusion criteria:

• fœtal ultrasound anomaly

Related Conditions & MeSH terms

• Digestive System Abnormalities
• Intestinal Malrotation
• Intestinal Volvulus

Intervention

Other:
• MRI between 30-35 GA
MRI between 30-35 GA
• Pediatric surgeon meeting
Pediatric surgeon meeting
• Postnatal abdominal ultrasound, barium enema and upper gastrointestinal
Postnatal abdominal ultrasound, barium enema and upper gastrointestinal
• +/- prophylactic surgery
+/- prophylactic surgery

Locations

Country	Name	City	State
France	Uhmontpellier	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	Reproducibility of ultrasound in the diagnosis of the abnormal position of the mesenteric vessels	Feasibility study to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.	1 day (Pre and post natal ultrasound)
Primary	Antenatal screening of intestinal malrotation	Antenatal screening of intestinal malrotation with higher risk of volvulus.	1 day (Pre and post natal ultrasound)
Primary	Future of the children with an ante natal diagnosis of intestinal malrotation	Future of the children with an ante natal diagnosis of intestinal malrotation	1 year after birth
Secondary	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 (During Pregnancy)
Secondary	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)