Prenatal US Assessment of Superior Mesenteric Vessels for Digestive Rotation (SMA)

January 10, 2022 updated by: University Hospital, Montpellier

Prenatal Ultrasound Assessment of the Relative Position of the Superior Mesenteric Artery and Vein to Define the Status of Digestive Rotation: a Prenatal Tool of Intestinal Malrotation Diagnosis?

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 ti evaluate the ability to identiy prenataly during ultrasound examination, the relative positionning of the fetal mesenteric vessels, and then to correlate it with the real postnatal positionning (gold standard)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Prenatal US assessment of mesenteric vessels positioning (relative position of the vein vs artery) during routine 3rd trimester US scan
  • Description of various anatomical situation
  • Comparison of this prenatal positioning with postnatal positioning obtained through abdominal ultrasound examination. Post-natal ultrasound being the gold standard

Study Type

Observational

Enrollment (Actual)

80

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 3rd timester scan

Description

Inclusion criteria:

  • Pregnant women attending for 3rd trimester ukltrasound
  • Uneventfull pregnancy
  • No foetal malformation
  • Singleton pregnancy
  • Age >18 years

Exclusion criteria:

- Other condition

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal foetus
All pregnant women reffered for 3rd trimester routine ultrasound examination without any fetal abnormality
Other: Ultrasound exam
Ultrasound exam
Other: Postnatal abdominal ultrasound
Postnatal abdominal ultrasound
Other: Pediatric Follow up
Pediatric Follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prenatal ultrasound evaluation
Time Frame: day 1
Prenatal ultrasound evaluation, during 3rd trimester routine scan, of the relative positioning of the superior mesenteric vein in comparison to the superior mesenteric artery
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prenatal ultrasound evaluation
Time Frame: day 1
Prenatal ultrasound evaluation, during 3rd trimester routine scan, of the relative positioning of the superior mesenteric artery in comparison to the superior mesenteric vein
day 1
Prenatal ultrasound evaluation
Time Frame: day 1
Prenatal ultrasound evaluation, during 3rd trimester routine scan, of the relative positioning of the superior mesenteric artery in comparison to the superior mesenteric aorta
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)

June 1, 2021

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL21_0683

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

product manufactured in and exported from the U.S.

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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