Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus.

Postnatal Complication Clinical Trial

— MALROT  

Official title:

Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of the Ultrasound Study of the Relative Position of the Superior Mesenteric Vessels and Fetal Abdominal MRI.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148429
• Other study ID #: RECHMPL21_0684
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• 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 to study the neonatal outcome of fetus confirm to have an abnormal positionning of mesenteric vessels

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 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 2nd trimester ultrasound
• Abnormal positionning of mesenteric vessels
• No other foetal malformation
• Singleton pregnancy
• Age >18 years

Exclusion criteria:

• Chromosomal abnormality
• polymalformative syndrom
• Foetal malformation changing intestine disposition (gastroschisis, diaphragmatic hernia, heterotaxis…)

Related Conditions & MeSH terms

• Intestinal Volvulus
• Postnatal Complication

Intervention

Other:
• Ultrasound exam
Ultrasound exam
• Fetal MRI
Fetal MRI
• 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	Percentage of intestinal malrotation among foetuses	Percentage of intestinal malrotation among foetuses with abnormal positionning of mesenteric vessels	day 1
Secondary	Rate of correlation between prenatal	Rate of correlation between prenatal	day 1
Secondary	Rate of postnatal ultrasound	Rate of postnatal ultrasound	day 1
Secondary	type of intestinal malrotation	type of intestinal malrotation	day 1