Prenatal Screening of Intestinal Malrotation With a Highe... | NCT05148429

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

NCT05148429

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Dec 23, 2021Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Postnatal Complication
Mesenteric Pregnancy

Interventions

Ultrasound exam
Fetal MRI
Postnatal abdominal ultrasound
Pediatric Follow up

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Oct 1, 2021Actual

Completion Date

Nov 1, 2021Actual

First Submitted Date

Nov 24, 2021

First Submission Date that Met QC Criteria

Nov 24, 2021

First Posted Date

Dec 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2021

Last Update Posted Date

Dec 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound exam	Other	Ultrasound exam	Fetuses with abnormal positionning of mesenteric vessels

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of intestinal malrotation among foetuses	Percentage of intestinal malrotation among foetuses with abnormal positionning of mesenteric vessels	day 1

Secondary Outcomes

Measure	Description	Time Frame
Rate of correlation between prenatal	Rate of correlation between prenatal	day 1
Rate of postnatal ultrasound	Rate of postnatal ultrasound

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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…)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women attending for 2nd trimester scan

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Florent FUCHS, PhD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided