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CompletedNCT03356314VOLMESUpdated Apr 24, 2018

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

An observational study in Intestinal Malrotation, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-24.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
9,000
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Intestinal Malrotation

Keywords

  • superior mesenteric artery
  • superior mesenteric vein
  • intestinal malrotation
  • volvulus
  • pregnant women
  • mesenteric vessels position
  • postnatal diagnosis
  • prophylactic surgery
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All pregnant women

Inclusion criteria

  • pregnant women
  • second or third trimester ultrasound.

Exclusion criteria

Exclusion criteria:

  • fœtal ultrasound anomaly
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
9,000 participants (actual)
Patient registry
No

Interventions

  • OtherMRI between 30-35 GA

    MRI between 30-35 GA

  • OtherPediatric surgeon meeting

    Pediatric surgeon meeting

  • OtherPostnatal abdominal ultrasound, barium enema and upper gastrointestinal

    Postnatal abdominal ultrasound, barium enema and upper gastrointestinal

  • Other+/- prophylactic surgery

    +/- prophylactic surgery

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day (Pre and post natal ultrasound)

  2. Antenatal screening of intestinal malrotation

    Antenatal screening of intestinal malrotation with higher risk of volvulus.

    Time frame: 1 day (Pre and post natal ultrasound)

  3. Future of the children with an ante natal diagnosis of intestinal malrotation

    Future of the children with an ante natal diagnosis of intestinal malrotation

    Time frame: 1 year after birth

Secondary outcomes

  1. Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.

    Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.

    Time frame: 1 day (During Pregnancy)

  2. Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.

    Produce ante and postnatal strategy facing a situation of mesenteric vessels malposition.

    Time frame: 1 day (after delivery)

06

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
07

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03356314
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Nov 29, 2017
Start date
Jan 1, 2017
Primary completion
May 1, 2017
Completion
Dec 1, 2017
Last update
Apr 24, 2018

Study contacts

florent FUCHS
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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