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OpenTrials
Completed

NCT Number: NCT03356314

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women
  • second or third trimester ultrasound.

Exclusion criteria

  • fœtal ultrasound anomaly

Treatment and study plan

MRI between 30-35 GA

Other

MRI between 30-35 GA

Pediatric surgeon meeting

Other

Pediatric surgeon meeting

Postnatal abdominal ultrasound, barium enema and upper gastrointestinal

Other

Postnatal abdominal ultrasound, barium enema and upper gastrointestinal

+/- prophylactic surgery

Other

+/- prophylactic surgery

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: VOLMES

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2017
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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