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

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Completed
• CT.gov ID: NCT05148429
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 22
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postnatal Complication; Mesenteric Pregnancy	Other: Ultrasound exam; Other: Fetal MRI; Other: Postnatal abdominal ultrasound; Other: Pediatric Follow up

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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.
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Fetuses with abnormal positionning of mesenteric vessels All pregnant women with abnormal positionning of mesenteric vessels during second trimester scan	Other: Ultrasound exam; Ultrasound exam; Other: Fetal MRI; Fetal MRI; Other: Postnatal abdominal ultrasound; Postnatal abdominal ultrasound; Other: Pediatric Follow up; Pediatric Follow up

Outcome Measures

Primary Outcome Measures

1. Percentage of intestinal malrotation among foetuses [day 1]

   Percentage of intestinal malrotation among foetuses with abnormal positionning of mesenteric vessels

Secondary Outcome Measures

1. Rate of correlation between prenatal [day 1]

   Rate of correlation between prenatal

2. Rate of postnatal ultrasound [day 1]

   Rate of postnatal ultrasound

3. type of intestinal malrotation [day 1]

   type of intestinal malrotation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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…)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhmontpellier	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

• Principal Investigator: Florent FUCHS, PhD, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT05148429
• Other Study ID Numbers: RECHMPL21_0684
• First Posted: Dec 8, 2021
• Last Update Posted: Dec 23, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Montpellier: Pregnant women; 2nd trimester ultrasound examination; Mesenteric vessels positionning; Pediatric follow up +/- treatment; Postnatal confirmation; Evolution and complication
• Additional relevant MeSH terms: Intestinal Volvulus

Study Results

No Results Posted as of Dec 23, 2021