Pregnancy RelatedMALGRENCT03968107
Diagnostic Performance of Antenatal Ultrasound for High-Risk Intestinal Malrotation
An observational study of Pregnancy Related, run by University Hospital, Montpellier at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Reference ultrasound examination
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2019to 4 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women with normal intestinal structure and requiring a fetal MRI for other reason
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance of Antenatal Ultrasound in the Localization of Intestinal Structures Involved in Malrotation With a Higher-risk of Volvulus
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.
- Conditions
- Pregnancy Related
- Being tested
- Reference ultrasound examination
- Keywords
- malrotation, intestinal structures, mesenteric vessels, prenatal diagnosis, congenital abnormalities, digestive system abnormalities, torsion abnormality, intestinal volvulus
- Medical subject headings
- Volvulus Of Midgut, Congenital Abnormalities, Digestive System Abnormalities, Torsion Abnormality, Intestinal Volvulus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference ultrasound examinationOther
Also called Fetal MRI, Comparison of both results
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Reference ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: At the visit 1 of the subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start27 Nov 2019
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Why it stopped: The study was terminated prematurely, as the inclusion period ended on 11/27/2024. Of the 103 patients planned, 77 were included.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Responsible party
- Sponsor
- Investigators
- Florent FUCHS, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968107
- Sponsor's protocol ID
- RECHMPL18_0454 UF 7722
- Other IDs
- 2019-A00614-53
- Acronym
- MALGRE
- Status last verified
- Dec 2025
- First submitted
- 27 May 2019
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 15868599Orzech 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 16677901Dufour 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 1594305Saguintaah 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 12029338Boylan P, Parisi V. An overview of hydramnios. Semin Perinatol. 1986 Apr;10(2):136-41.
PubMed 3541223Veyrac 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 15767925Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
PubMed 843571Veyrac 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 22395723Couture 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 16302344Veyrac 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 15136891Faure 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Antenatal Ultrasound in the Localization of Intestinal Structures Involved in Malrotation With a Higher-risk of Volvulus
- ClinicalTrials.gov ID
- NCT03968107
- Acronym / sponsor ID
- MALGRE / RECHMPL18_0454 UF 7722
- Conditions
- Pregnancy Related
- Keywords
- malrotation, intestinal structures, mesenteric vessels, prenatal diagnosis, congenital abnormalities, digestive system abnormalities, torsion abnormality, intestinal volvulus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely, as the inclusion period ended on 11/27/2024. Of the 103 patients planned, 77 were included.
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with a pregnancy of at least 31 weeks | – | Other: Reference ultrasound examinationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with normal intestinal structure and requiring a fetal MRI for other reason
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reference ultrasound examinationAlso: Fetal MRI, Comparison of both resultsUse 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 | Women with a pregnancy of at least 31 weeks |
Primary outcome
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)
1 secondary outcome
normal meconium progression
Time frame: At the visit 1 of the subjects
Results and safety
The study was stopped early (reason given: The study was terminated prematurely, as the inclusion period ended on 11/27/2024. Of the 103 patients planned, 77 were included.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 15868599Malek 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.
- Background: PubMed 16677901Orzech 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.
- Background: PubMed 1594305Dufour 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.
- Background: PubMed 12029338Saguintaah 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.
- Background: PubMed 3541223Boylan P, Parisi V. An overview of hydramnios. Semin Perinatol. 1986 Apr;10(2):136-41.
- Background: PubMed 15767925Veyrac 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.
- Background: PubMed 843571Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
- Background: PubMed 22395723Veyrac 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.
- Background: PubMed 16302344Couture 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.
- Background: PubMed 15136891Veyrac 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.
- Background: PubMed 32673416Faure 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florent FUCHS, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated prematurely, as the inclusion period ended on 11/27/2024. Of the 103 patients planned, 77 were included.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut) (time frame: At the visit 1 of the subjects). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968107, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.