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

Completed

• Conditions: Mesenteric Pregnancy; Postnatal Complication
• Interventions: Other: Ultrasound exam; Other: Fetal MRI; Other: Postnatal abdominal ultrasound; Other: Pediatric Follow up

• Registration Number: NCT05148429
• 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 to study the neonatal outcome of fetus confirm to have an abnormal positionning of mesenteric vessels

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-10-01
• Status Verified: 2021-11
• Study Completion: 2021-11-01
• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-08
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2021-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fetuses with abnormal positionning of mesenteric vessels	Fetal MRI	All pregnant women with abnormal positionning of mesenteric vessels during second trimester scan
Fetuses with abnormal positionning of mesenteric vessels	Postnatal abdominal ultrasound	All pregnant women with abnormal positionning of mesenteric vessels during second trimester scan
Fetuses with abnormal positionning of mesenteric vessels	Pediatric Follow up	All pregnant women with abnormal positionning of mesenteric vessels during second trimester scan
Fetuses with abnormal positionning of mesenteric vessels	Ultrasound exam	All pregnant women with abnormal positionning of mesenteric vessels during second trimester scan

Primary Outcome Measures

Name	Time	Method
Percentage of intestinal malrotation among foetuses	day 1	Percentage of intestinal malrotation among foetuses with abnormal positionning of mesenteric vessels

Secondary Outcome Measures

Name	Time	Method
Rate of correlation between prenatal	day 1	Rate of correlation between prenatal
Rate of postnatal ultrasound	day 1	Rate of postnatal ultrasound
type of intestinal malrotation	day 1	type of intestinal malrotation

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France