Prenatal Ultrasound Screening of Intestinal Malrotation With a Higher Risk of Volvulus
VOLMES
VOLMES
Sponsor study identifier
observational
9,000
1 country
1
Study Start
January 1, 2017
Actual (reported)Primary Completion
May 1, 2017
Actual (reported)Study Completion
December 1, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2017
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2017
Actual (reported)May 1, 2017
Actual (reported)October 12, 2017
Actual (reported)November 29, 2017
Actual (reported)December 1, 2017
Actual (reported)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)
Antenatal screening of intestinal malrotation
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
Future of the children with an ante natal diagnosis of intestinal malrotation
1 year after birth
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.
1 day (after delivery)
MRI between 30-35 GA
Pediatric surgeon meeting
All pregnant women
Uhmontpellier
Montpellier, 34295, France
florent FUCHS
University Hospital, Montpellier
9,000 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2017
First Posted
November 29, 2017
Study Start
January 1, 2017
Actual (reported)Postnatal abdominal ultrasound, barium enema and upper gastrointestinal
+/- prophylactic surgery
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Primary Completion
May 1, 2017
Actual (reported)Study Completion
December 1, 2017
Actual (reported)Last Updated
April 24, 2018
Record last verified: 2017-10
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