NCT05204771

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

November 24, 2021

Last Update Submit

January 10, 2022

Conditions

Singleton-Merten SyndromePostnatal Complication

Keywords

Evolution and complicationMesenteric vessels positionning3rd ultrasound examinationPediatric follow up +/- treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Prenatal ultrasound evaluation

    day 1

  • Prenatal ultrasound evaluation

    day 1

Study Arms (1)

Normal foetus

All pregnant women reffered for 3rd trimester routine ultrasound examination without any fetal abnormality

Other: Ultrasound examOther: Postnatal abdominal ultrasoundOther: Pediatric Follow up

Interventions

Ultrasound examOTHER

Ultrasound exam

Normal foetus
Postnatal abdominal ultrasoundOTHER

Postnatal abdominal ultrasound

Normal foetus
Pediatric Follow upOTHER

Pediatric Follow up

Normal foetus

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women attending for 3rd timester scan

You may qualify if:

  • Pregnant women attending for 3rd trimester ukltrasound
  • Uneventfull pregnancy
  • No foetal malformation
  • Singleton pregnancy
  • Age \>18 years

You may not qualify if:

  • \- Other condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Singleton Merten syndrome

Study Officials

  • Florent FUCHS, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

January 24, 2022

Study Start

June 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

January 24, 2022

Record last verified: 2022-01

Locations

FR(1)