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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05204771
Other study ID # RECHMPL21_0683
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date October 1, 2021

Study information

Verified date January 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication. The aim of the study is ti evaluate the ability to identiy prenataly during ultrasound examination, the relative positionning of the fetal mesenteric vessels, and then to correlate it with the real postnatal positionning (gold standard)


Description:

- Prenatal US assessment of mesenteric vessels positioning (relative position of the vein vs artery) during routine 3rd trimester US scan - Description of various anatomical situation - Comparison of this prenatal positioning with postnatal positioning obtained through abdominal ultrasound examination. Post-natal ultrasound being the gold standard


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria: - Pregnant women attending for 3rd trimester ukltrasound - Uneventfull pregnancy - No foetal malformation - Singleton pregnancy - Age >18 years Exclusion criteria: - Other condition

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ultrasound exam
Ultrasound exam
Postnatal abdominal ultrasound
Postnatal abdominal ultrasound
Pediatric Follow up
Pediatric Follow up

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prenatal ultrasound evaluation Prenatal ultrasound evaluation, during 3rd trimester routine scan, of the relative positioning of the superior mesenteric vein in comparison to the superior mesenteric artery day 1
Secondary Prenatal ultrasound evaluation Prenatal ultrasound evaluation, during 3rd trimester routine scan, of the relative positioning of the superior mesenteric artery in comparison to the superior mesenteric vein day 1
Secondary Prenatal ultrasound evaluation Prenatal ultrasound evaluation, during 3rd trimester routine scan, of the relative positioning of the superior mesenteric artery in comparison to the superior mesenteric aorta day 1
See also
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Completed NCT05148429 - Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus.
Completed NCT03415321 - Development of Postnatal Mobile Support Application N/A