Prenatal US Assessment of Superior Mesenteric Vessels for Digestive Rotation

Completed

• Conditions: Singleton-Merten Syndrome; Postnatal Complication
• Interventions: Other: Ultrasound exam; Other: Postnatal abdominal ultrasound; Other: Pediatric Follow up

• Registration Number: NCT05204771
• Lead Sponsor: University Hospital, Montpellier

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 Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Study First Submitted: 2021-11-24
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-10
• Last Update Submitted: 2022-01-10
• Study First Posted: 2022-01-24
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Prenatal ultrasound evaluation	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 Outcome Measures

Name	Time	Method
Prenatal ultrasound evaluation	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

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France