- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05148429
Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus. (MALROT)
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.
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34295
- Uhmontpellier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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…)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fetuses with abnormal positionning of mesenteric vessels
All pregnant women with abnormal positionning of mesenteric vessels during second trimester scan
|
Ultrasound exam
Postnatal abdominal ultrasound
Pediatric Follow up
Fetal MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of intestinal malrotation among foetuses
Time Frame: day 1
|
Percentage of intestinal malrotation among foetuses with abnormal positionning of mesenteric vessels
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of correlation between prenatal
Time Frame: day 1
|
Rate of correlation between prenatal
|
day 1
|
Rate of postnatal ultrasound
Time Frame: day 1
|
Rate of postnatal ultrasound
|
day 1
|
type of intestinal malrotation
Time Frame: day 1
|
type of intestinal malrotation
|
day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Florent FUCHS, PhD, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL21_0684
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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