Diagnostic Performance of Antenatal Ultrasound for High-Risk Intestinal Malrotation

NCT03968107 | Terminated

• 2 other identifiers: RECHMPL18_0454 UF 77222019-A00614-53
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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 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.

Conditions

Pregnancy Related

Keywords

malrotation; intestinal structures; mesenteric vessels; prenatal diagnosis; congenital abnormalities; digestive system abnormalities; torsion abnormality; intestinal volvulus

Outcome Measures

Primary Outcomes (1)

• Ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut)

  The primary outcome will be ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut)

  At the visit 1 of the subjects

Secondary Outcomes (1)

• normal meconium progression

  At the visit 1 of the subjects

Study Arms (1)

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.

Other: Reference ultrasound examination

Interventions

Reference ultrasound examination OTHER

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.

Also known as: Fetal MRI, Comparison of both results

Women with a pregnancy of at least 31 weeks

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women with normal intestinal structure and requiring a fetal MRI for other reason

You may qualify if:

• Pregnant women over the age of 18
• 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

You may not qualify if:

• Complex fetal abdominal malformations responsible for difficult interpretation of imaging: heterotaxis with asplenia or polysplenium, diaphragmatic hernia, omphalocele, gastroschisis, digestive pathology, abdominal tumor, bladder exstrophy or megavessia.
• Fetal chromosomal abnormality
• Request for termination of pregnancy validated by a Multidisciplinary Pre-natal Diagnosis Center

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Centre Hospitalier Universitaire de Nīmes: collaborator

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

Location

Related Publications (11)

• 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.

  PMID: 15868599 BACKGROUND

• 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.

  PMID: 16677901 BACKGROUND

• 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.

  PMID: 1594305 BACKGROUND

• 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.

  PMID: 12029338 BACKGROUND

• Boylan P, Parisi V. An overview of hydramnios. Semin Perinatol. 1986 Apr;10(2):136-41.

  PMID: 3541223 BACKGROUND

• 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.

  PMID: 15767925 BACKGROUND

• Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.

  PMID: 843571 BACKGROUND

• 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.

  PMID: 22395723 BACKGROUND

• 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.

  PMID: 16302344 BACKGROUND

• 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.

  PMID: 15136891 BACKGROUND

• 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.

  PMID: 32673416 BACKGROUND

MeSH Terms

Conditions

Volvulus Of Midgut; Congenital Abnormalities; Digestive System Abnormalities; Torsion Abnormality; Intestinal Volvulus

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases

Study Officials

• Florent FUCHS, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: November 27, 2019
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)