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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00614-53 | Registry Identifier | ID-RCB |
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The study was terminated prematurely, as the inclusion period ended on 11/27/2024. Of the 103 patients planned, 77 were included.
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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire de Nīmes | OTHER |
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The aims of this study are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| normal meconium progression | Normal meconium progression will be described by the results of ultrasound examination and MRI | At the visit 1 of the subjects |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women with normal intestinal structure and requiring a fetal MRI for other reason
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| Name | Affiliation | Role |
|---|---|---|
| Florent FUCHS, MD, PhD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Montpellier | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15868599 | Background | 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. | |
| 16677901 | 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. |
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| ID | Term |
|---|---|
| C562456 | Volvulus Of Midgut |
| D000013 | Congenital Abnormalities |
| D004065 | Digestive System Abnormalities |
| D014102 | Torsion Abnormality |
| D045822 | Intestinal Volvulus |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004066 | Digestive System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1594305 | 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. |
| 12029338 | 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. |
| 3541223 | Background | Boylan P, Parisi V. An overview of hydramnios. Semin Perinatol. 1986 Apr;10(2):136-41. |
| 15767925 | 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. |
| 843571 | Background | Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. |
| 22395723 | 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. |
| 16302344 | 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. |
| 15136891 | 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. |
| 32673416 | 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. |
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |