Prenatal US Assessment of Superior Mesenteric Vessels for Digestive Rotation

Brief Title

Prenatal US Assessment of Superior Mesenteric Vessels for Digestive Rotation

Official Title

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?

Brief Summary

      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)
    

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


Primary Outcome

Prenatal ultrasound evaluation

Secondary Outcome

 Prenatal ultrasound evaluation

Condition

Singleton-Merten Syndrome

Intervention

Ultrasound exam

Study Arms / Comparison Groups

 Normal foetus
Description:  All pregnant women reffered for 3rd trimester routine ultrasound examination without any fetal abnormality

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

80

Start Date

June 1, 2021

Completion Date

October 1, 2021

Primary Completion Date

October 1, 2021

Eligibility Criteria

        Inclusion criteria:

          -  Pregnant women attending for 3rd trimester ukltrasound

          -  Uneventfull pregnancy

          -  No foetal malformation

          -  Singleton pregnancy

          -  Age >18 years

        Exclusion criteria:

        - Other condition
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Florent FUCHS, PhD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT05204771

Organization ID

RECHMPL21_0683


Responsible Party

Sponsor

Study Sponsor

University Hospital, Montpellier


Study Sponsor

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


Verification Date

January 2022