Diagnostic Performance of Antenatal Ultrasound in the Localization of Intestinal Structures Involved in Malrotation With a Higher-risk of Volvulus (MALGRE)
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|ClinicalTrials.gov Identifier: NCT03968107|
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : January 21, 2020
The aims of this study are:
- To assess the performance of third-trimester ultrasound scan in the localization of intestinal structures (small bowel, gut, mesenteric vessels..) involved in malrotations with a higher-risk of volvulus compared to a gold standard based on fetal MRI.
- To describe normal meconium progression (ultrasound and MRI), prenatal anatomical variants of the fetal digestive tract, and interobserver agreement on prenatal ultrasound.
|Condition or disease||Intervention/treatment|
|Pregnancy Related||Other: Reference ultrasound examination|
|Study Type :||Observational|
|Estimated Enrollment :||264 participants|
|Official Title:||Diagnostic Performance of Antenatal Ultrasound in the Localization of Intestinal Structures Involved in Malrotation With a Higher-risk of Volvulus|
|Actual Study Start Date :||November 27, 2019|
|Estimated Primary Completion Date :||November 27, 2021|
|Estimated Study Completion Date :||November 27, 2023|
Women with a singleton pregnancy over 28 weeks
All pregnant women with a singleton pregnancy over 28 weeks and having to perform a fetal MRI to identify a cerebral, pulmonary or renal fetal malformation, or due to a diagnostic doubt on ultrasound on an abnormality of these structures , will be proposed inclusion in the study.
Other: Reference ultrasound examination
Use of antenatal ultrasound examination to visualize and position the intestinal structures involved in digestive malrotation at high risk of volvulus and comparison to fetal MRI results.
- Ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut) [ Time Frame: At the visit 1 of the subjects ]The primary outcome will be ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut)
- normal meconium progression [ Time Frame: At the visit 1 of the subjects ]Normal meconium progression will be described by the results of ultrasound examination and MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968107
|Contact: Florent FUCHS, PhD||06 65 84 94 firstname.lastname@example.org|
|University Hospital of Montpellier||Recruiting|
|Contact: Florent FUCHS email@example.com|
|Principal Investigator:||Florent FUCHS, PhD||University Hospital, Montpellier|