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OpenTrials
Completed

NCT Number: NCT05204771

Prenatal US Assessment of Superior Mesenteric Vessels for Digestive Rotation

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)

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Other condition

Treatment and study plan

Ultrasound exam

Other

Ultrasound exam

Postnatal abdominal ultrasound

Other

Postnatal abdominal ultrasound

Pediatric Follow up

Other

Pediatric Follow up

Primary outcomes

  1. 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

Secondary outcomes

  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 vein

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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?

Acronym: SMA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2022
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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