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

NCT ID: NCT03356314

Last Updated: 2018-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Intestinal Malrotation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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MRI between 30-35 GA

MRI between 30-35 GA

Intervention Type OTHER

Pediatric surgeon meeting

Pediatric surgeon meeting

Intervention Type OTHER

Postnatal abdominal ultrasound, barium enema and upper gastrointestinal

Postnatal abdominal ultrasound, barium enema and upper gastrointestinal

Intervention Type OTHER

+/- prophylactic surgery

+/- prophylactic surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* pregnant women
* second or third trimester ultrasound.

Exclusion Criteria

* fœtal ultrasound anomaly
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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florent FUCHS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL17_0258

Identifier Type: -

Identifier Source: org_study_id

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