NCT05148429

Completed

Prenatal Screening of Intestinal Malrotation With a Higher R...

University Hospital, Montpellier Source

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Other study identifiers

Sponsor study identifier

RECHMPL21_0684

Study Type

observational

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

January 1, 2020

Actual (reported)

Primary Completion

October 1, 2021

Actual (reported)

Study Completion

November 1, 2021

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: November 1, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1, 2020
Actual (reported)
Primary Completion
October 1, 2021
Actual (reported)
Study Completion
November 1, 2021
Actual (reported)
First Submitted
November 24, 2021
Actual (reported)
First Posted
December 8, 2021
Actual (reported)

Last Updated: December 23, 2021
Status Verified: November 2021
Last Update Submitted: December 22, 2021

Conditions

Mesenteric Pregnancy Postnatal Complication

Keywords

Pregnant women2nd trimester ultrasound examinationMesenteric vessels positionningPediatric follow up +/- treatmentPostnatal confirmationEvolution and complication

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

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

Study Arms (1)

Fetuses with abnormal positionning of mesenteric vessels

All pregnant women with abnormal positionning of mesenteric vessels during second trimester scan

Other: Ultrasound examOther: Fetal MRIOther: Postnatal abdominal ultrasoundOther: Pediatric Follow up

Interventions

Ultrasound examOther

Ultrasound exam

Fetuses with abnormal positionning of mesenteric vessels

Fetal MRIOther

Fetal MRI

Fetuses with abnormal positionning of mesenteric vessels

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Pregnant women attending for 2nd trimester scan

You may qualify if:

Pregnant women attending for 2nd trimester ultrasound

Sponsors & Collaborators

University Hospital, Montpellier
Otherlead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Study Officials

Florent FUCHS, PhD
University Hospital, Montpellier
PRINCIPAL INVESTIGATOR

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

December 8, 2021

Study Start

January 1, 2020

Actual (reported)

Not ApplicableCompleted

Postnatal abdominal ultrasoundOther

Postnatal abdominal ultrasound

Fetuses with abnormal positionning of mesenteric vessels

Pediatric Follow upOther

Pediatric Follow up

Fetuses with abnormal positionning of mesenteric vessels

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Abnormal positionning of mesenteric vessels

No other foetal malformation

Singleton pregnancy

Age \>18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

October 1, 2021

Actual (reported)

Study Completion

November 1, 2021

Actual (reported)

Last Updated

December 23, 2021

Record last verified: 2021-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05148429
Data provider: ClinicalTrials.gov
Source updated: 2021-12-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:37 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Fetuses with abnormal positionning of mesenteric vessels

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations