Prenatal US Assessment of Superior Mesenteric Vessels for Digestive Rotation

Postnatal Complication Clinical Trial

— SMA  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05204771
• Other study ID #: RECHMPL21_0683
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Pregnant women attending for 3rd trimester ukltrasound

• Uneventfull pregnancy

• No foetal malformation

• Singleton pregnancy

• Age >18 years

Exclusion criteria:

• Other condition

Related Conditions & MeSH terms

• Postnatal Complication

Intervention

Other:
• Ultrasound exam
Ultrasound exam
• Postnatal abdominal ultrasound
Postnatal abdominal ultrasound
• Pediatric Follow up
Pediatric Follow up

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prenatal ultrasound evaluation	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	Prenatal ultrasound evaluation	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
Secondary	Prenatal ultrasound evaluation	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