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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03356314
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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
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
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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 : January 1, 2017
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : December 1, 2017
Groups and Cohorts
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Intervention Details:
  • Other: MRI between 30-35 GA
    MRI between 30-35 GA
  • Other: Pediatric surgeon meeting
    Pediatric surgeon meeting
  • Other: Postnatal abdominal ultrasound, barium enema and upper gastrointestinal
    Postnatal abdominal ultrasound, barium enema and upper gastrointestinal
  • Other: +/- prophylactic surgery
    +/- prophylactic surgery

Outcome Measures
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Primary Outcome Measures :
  1. Reproducibility of ultrasound in the diagnosis of the abnormal position of the mesenteric vessels [ Time Frame: 1 day (Pre and post natal ultrasound) ]
    Feasibility study to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.

  2. Antenatal screening of intestinal malrotation [ Time Frame: 1 day (Pre and post natal ultrasound) ]
    Antenatal screening of intestinal malrotation with higher risk of volvulus.

  3. Future of the children with an ante natal diagnosis of intestinal malrotation [ Time Frame: 1 year after birth ]
    Future of the children with an ante natal diagnosis of intestinal malrotation


Secondary Outcome Measures :
  1. Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition. [ Time Frame: 1 day (During Pregnancy) ]
    Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.

  2. Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition. [ Time Frame: 1 day (after delivery) ]
    Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All pregnant women
Criteria

Inclusion criteria:

  • pregnant women
  • second or third trimester ultrasound.

Exclusion criteria:

  • fœtal ultrasound anomaly
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356314


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: florent FUCHS University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03356314    
Other Study ID Numbers: RECHMPL17_0258
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
superior mesenteric artery
superior mesenteric vein
intestinal malrotation
volvulus
 pregnant women
mesenteric vessels position
postnatal diagnosis
prophylactic surgery
Additional relevant MeSH terms:
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Intestinal Volvulus
Digestive System Abnormalities
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Torsion Abnormality
Pathological Conditions, Anatomical
Congenital Abnormalities