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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03356314
Acronym
VOLMES
Enrollment
9000
Registered
2017-11-29
Start date
2017-01-01
Completion date
2017-12-01
Last updated
2018-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Malrotation

Keywords

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

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.

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* pregnant women * second or third trimester ultrasound.

Exclusion criteria

* fœtal ultrasound anomaly

Design outcomes

Primary

MeasureTime frameDescription
Reproducibility of ultrasound in the diagnosis of the abnormal position of the mesenteric vessels1 day (Pre and post natal ultrasound)Feasibility study to prove the reproducibility of ultrasound in diagnosis of anormal mesenteric vessels position.
Antenatal screening of intestinal malrotation1 day (Pre and post natal ultrasound)Antenatal screening of intestinal malrotation with higher risk of volvulus.
Future of the children with an ante natal diagnosis of intestinal malrotation1 year after birthFuture of the children with an ante natal diagnosis of intestinal malrotation

Secondary

MeasureTime frameDescription
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026