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

April 23, 2018 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • UHMontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All pregnant women

Description

Inclusion criteria:

  • pregnant women
  • second or third trimester ultrasound.

Exclusion criteria:

  • fœtal ultrasound anomaly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day (Pre and post natal ultrasound)
Antenatal screening of intestinal malrotation
Time Frame: 1 day (Pre and post natal ultrasound)
Antenatal screening of intestinal malrotation with higher risk of volvulus.
1 day (Pre and post natal ultrasound)
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
1 year after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day (During Pregnancy)
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.
1 day (after delivery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: florent FUCHS, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL17_0258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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