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TerminatedNCT03968107MALGREUpdated Jan 5, 2026

Diagnostic Performance of Antenatal Ultrasound for High-Risk Intestinal Malrotation

An observational study in Pregnancy Related, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by University Hospital, Montpellier · Observational

Why this study was terminated
The study was terminated prematurely, as the inclusion period ended on 11/27/2024. Of the 103 patients planned, 77 were included.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
77
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Congenital Abnormalities with a site in France — 10 open to participants now, 13 under way, none of them phase 3. Congenital Abnormalities · France.

Enrollment
14th of 24
77 · median 95
Started
2019
with 4 others
Observational
24 of 56
6 open now
Registered
37th of 56
by date
Lead sponsor
3 of 56
University Hospital, Montpellier

Among the 56 studies in Congenital Abnormalities with a site in France, this one is the 14th largest by enrollment of the 24 observational ones, is one of 5 that started in 2019, is one of 24 observational ones, and was the 37th registered.

By phase

56 studies; the count open now beside each. This study's row is marked.

Observationalthis study24 · 6 open
No phase19 · 4 open
Phase 25 · 0 open
Phase 1/23 · 0 open
Phase 33 · 0 open
Phase 12 · 0 open

By the year they started

First in 2002; this study’s year is marked. 5 started in 2019.

Size and results

Median enrollment 102 across the 32 interventional studies, 95 across the 24 observational. Of the 37 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 56 studies in Congenital Abnormalities with a site in France, or all of them as a file.
02

Study 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.
Read the detailed description

Introduction: Intestinal malrotation is a rare congenital anomaly resulting from abnormal rotation and fixation of the intestine during embryonic development. It is rarely asymptomatic and most often presents in the neonatal period with obstructive complications, including duodenal obstruction and, most critically, midgut volvulus. Midgut volvulus constitutes a surgical emergency due to the risk of extensive intestinal ischemia and necrosis, which may lead to short bowel syndrome or death.

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.

03

Conditions studied

  • Pregnancy Related

Keywords

  • malrotation
  • intestinal structures
  • mesenteric vessels
  • prenatal diagnosis
  • congenital abnormalities
  • digestive system abnormalities
  • torsion abnormality
  • intestinal volvulus
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
77 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherReference 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.

    Also known as: Fetal MRI, Comparison of both results

06

What researchers measure

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)

    Time frame: At the visit 1 of the subjects

Secondary outcomes

  1. normal meconium progression

    Normal meconium progression will be described by the results of ultrasound examination and MRI

    Time frame: At the visit 1 of the subjects

07

Study locations

1 site
  • University Hospital of Montpellier
    Montpellier, 34295, France
08

References and documents

Publications

  • 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. PubMed 15868599 ↗
  • 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. PubMed 16677901 ↗
  • 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. PubMed 1594305 ↗
  • 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. PubMed 12029338 ↗
  • Boylan P, Parisi V. An overview of hydramnios. Semin Perinatol. 1986 Apr;10(2):136-41. PubMed 3541223 ↗
  • 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. PubMed 15767925 ↗
  • Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. PubMed 843571 ↗
  • 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. PubMed 22395723 ↗
  • 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. PubMed 16302344 ↗
  • 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. PubMed 15136891 ↗
  • 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. PubMed 32673416 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2019 to primary completion in Apr 2023, 40 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2019
First posted
May 30, 2019
StartActual
Nov 27, 2019
Primary completionActual
Apr 4, 2023
CompletionActual
Apr 4, 2023
Last update
Jan 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03968107
Responsible party
Sponsor
First posted
May 30, 2019
Start date
Nov 27, 2019
Primary completion
Apr 4, 2023
Completion
Apr 4, 2023
Last update
Jan 5, 2026

Study contacts

Florent FUCHS, MD, PhD
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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