Diagnostic Performance of Antenatal Ultrasound for High-Risk Intestinal Malrotation
NCT ID: NCT03968107
Last Updated: 2026-01-05
Study Results
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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TERMINATED
77 participants
OBSERVATIONAL
2019-11-27
2023-04-04
Brief Summary
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* 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 magnetic resonance imaging (MRI).
* To describe normal meconium progression (ultrasound and MRI), prenatal anatomical variants of the fetal digestive tract, and interobserver agreement on prenatal ultrasound.
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Detailed Description
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Currently, there is no prenatal screening strategy for intestinal malrotation, and the feasibility and diagnostic performance of third-trimester obstetric ultrasound for detecting intestinal malrotation have never been formally evaluated.
Aim: To evaluate the diagnostic performance of third-trimester obstetric ultrasound in identifying the intestinal structures involved in high-risk intestinal malrotation associated with volvulus, using fetal MRI as the reference standard.
Methods : Eligible pregnant women will be identified during routine obstetric follow-up at Nîmes or Montpellier University Hospitals and enrolled exclusively in Montpellier. Each participant will undergo a third-trimester obstetric ultrasound and fetal MRI on the same day. Examinations will be performed independently by a senior obstetrician and a senior pediatric radiologist, both blinded to the other modality. Ultrasound visualization of mesenteric vessels, small bowel, and cecum will be compared with fetal MRI findings as the reference standard. Interobserver agreement for ultrasound interpretation will be assessed, and analyses will be stratified by gestational age. Participation duration is one day.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women with a pregnancy of at least 31 weeks
All pregnant women with a pregnancy of at least 31 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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Good understanding of French
* Gestational age greater than or equal than 31 weeks
* Fetal MRI indication validated in multidisciplinary staff at weekly meetings of the Multidisciplinary Prenatal Diagnosis Center in Montpellier or Nimes
* Affiliation or beneficiary of a social security scheme
* Declaration of free and enlightened opposition
Exclusion Criteria
* Fetal chromosomal abnormality
* Request for termination of pregnancy validated by a Multidisciplinary Pre-natal Diagnosis Center
18 Years
FEMALE
Yes
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Florent FUCHS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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University Hospital of Montpellier
Montpellier, , France
Countries
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References
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Malek MM, Burd RS. Surgical treatment of malrotation after infancy: a population-based study. J Pediatr Surg. 2005 Jan;40(1):285-9. doi: 10.1016/j.jpedsurg.2004.09.028.
Orzech N, Navarro OM, Langer JC. Is ultrasonography a good screening test for intestinal malrotation? J Pediatr Surg. 2006 May;41(5):1005-9. doi: 10.1016/j.jpedsurg.2005.12.070.
Dufour D, Delaet MH, Dassonville M, Cadranel S, Perlmutter N. Midgut malrotation, the reliability of sonographic diagnosis. Pediatr Radiol. 1992;22(1):21-3. doi: 10.1007/BF02011604.
Saguintaah M, Couture A, Veyrac C, Baud C, Quere MP. MRI of the fetal gastrointestinal tract. Pediatr Radiol. 2002 Jun;32(6):395-404. doi: 10.1007/s00247-001-0607-1. Epub 2002 Feb 16.
Boylan P, Parisi V. An overview of hydramnios. Semin Perinatol. 1986 Apr;10(2):136-41.
Veyrac C, Couture A, Saguintaah M, Baud C. [MRI of fetal GI tract]. J Gynecol Obstet Biol Reprod (Paris). 2005 Feb;34(1 Suppl):S14-7. doi: 10.1016/s0368-2315(05)82681-x. French.
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
Veyrac C, Baud C, Prodhomme O, Saguintaah M, Couture A. US assessment of neonatal bowel (necrotizing enterocolitis excluded). Pediatr Radiol. 2012 Jan;42 Suppl 1:S107-14. doi: 10.1007/s00247-011-2173-5. Epub 2012 Mar 6.
Couture A, Veyrac C, Baud C, Saguintaahi M. [Imaging in neonatal intestinal obstruction]. JBR-BTR. 2005 Sep-Oct;88(5):259-61. No abstract available. French.
Veyrac C, Couture A, Saguintaah M, Baud C. MRI of fetal GI tract abnormalities. Abdom Imaging. 2004 Jul-Aug;29(4):411-20. doi: 10.1007/s00261-003-0147-2. Epub 2004 May 12.
Faure JM, Mousty E, Bigorre M, Wells C, Boulot P, Captier G, Fuchs F. Prenatal ultrasound diagnosis of cleft palate without cleft lip, the new ultrasound semiology. Prenat Diagn. 2020 Oct;40(11):1447-1458. doi: 10.1002/pd.5794. Epub 2020 Aug 17.
Other Identifiers
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2019-A00614-53
Identifier Type: REGISTRY
Identifier Source: secondary_id
RECHMPL18_0454 UF 7722
Identifier Type: -
Identifier Source: org_study_id
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