Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus. (MALROT)

December 22, 2021 updated by: University Hospital, Montpellier

Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of the Ultrasound Study of the Relative Position of the Superior Mesenteric Vessels and Fetal Abdominal MRI.

Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication.

The aim of the study is to study the neonatal outcome of fetus confirm to have an abnormal positionning of mesenteric vessels

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women attending for 2nd trimester scan

Description

Inclusion criteria:

  • Pregnant women attending for 2nd trimester ultrasound
  • Abnormal positionning of mesenteric vessels
  • No other foetal malformation
  • Singleton pregnancy
  • Age >18 years

Exclusion criteria:

  • Chromosomal abnormality
  • polymalformative syndrom
  • Foetal malformation changing intestine disposition (gastroschisis, diaphragmatic hernia, heterotaxis…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fetuses with abnormal positionning of mesenteric vessels
All pregnant women with abnormal positionning of mesenteric vessels during second trimester scan
Other: Ultrasound exam
Ultrasound exam
Other: Postnatal abdominal ultrasound
Postnatal abdominal ultrasound
Other: Pediatric Follow up
Pediatric Follow up
Other: Fetal MRI
Fetal MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of intestinal malrotation among foetuses
Time Frame: day 1
Percentage of intestinal malrotation among foetuses with abnormal positionning of mesenteric vessels
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of correlation between prenatal
Time Frame: day 1
Rate of correlation between prenatal
day 1
Rate of postnatal ultrasound
Time Frame: day 1
Rate of postnatal ultrasound
day 1
type of intestinal malrotation
Time Frame: day 1
type of intestinal malrotation
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Florent FUCHS, PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

December 23, 2021

Last Update Submitted That Met QC Criteria

December 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL21_0684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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