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

NCT ID: NCT05148429

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-11-01

Brief Summary

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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

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Conditions

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Postnatal Complication Mesenteric Pregnancy

Keywords

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Pregnant women 2nd trimester ultrasound examination Mesenteric vessels positionning Pediatric follow up +/- treatment Postnatal confirmation Evolution and complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fetuses with abnormal positionning of mesenteric vessels

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

Ultrasound exam

Intervention Type OTHER

Ultrasound exam

Fetal MRI

Intervention Type OTHER

Fetal MRI

Postnatal abdominal ultrasound

Intervention Type OTHER

Postnatal abdominal ultrasound

Pediatric Follow up

Intervention Type OTHER

Pediatric Follow up

Interventions

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Ultrasound exam

Ultrasound exam

Intervention Type OTHER

Fetal MRI

Fetal MRI

Intervention Type OTHER

Postnatal abdominal ultrasound

Postnatal abdominal ultrasound

Intervention Type OTHER

Pediatric Follow up

Pediatric Follow up

Intervention Type OTHER

Eligibility Criteria

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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…)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florent FUCHS, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL21_0684

Identifier Type: -

Identifier Source: org_study_id