NCT03362450

Brief Summary

Objective: The small bowel volvulus is a rare cause of intestinal obstruction which may occur in utero and whose prenatal diagnosis is difficult.Sonographic signs are mainly indirect and non specific.The aim of this study is to present a retrospective analysis of prenatal sonographicfindings in fetal segmental midgut volvulus.Thanks to this series the investigators could highlight the more specifics signs of the volvulus included a new pattern.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
Last Updated

December 5, 2017

Status Verified

October 1, 2017

Enrollment Period

11.5 years

First QC Date

October 25, 2017

Last Update Submit

December 4, 2017

Conditions

Fetal VolvulusMidgut Volvulus

Keywords

Midgut volvulusFetal volvulusWhirlpool signPregnant womenPosition of mesenteric vesselsPost natal surgeryFoetopathology if performedHydro-meconium level in the dilated loops

Outcome Measures

Primary Outcomes (2)

  • echography

    Observation of specific signs using echography for the diagnosis of fetal during the second (22-24 weeks) and the third (31-34 weeks) trimester after ultrasound screening and when diagnostic ultrasound were performedmidgut volvulus

    during the second (22-24 weeks) after ultrasound screening

  • echography

    Observation of specific signs using echography for the diagnosis of fetal

    the third (31-34 weeks) trimester after ultrasound screening

Secondary Outcomes (12)

  • ultrasound signs of complication

    the third (31-34 weeks) after ultrasound screening

  • ultrasound signs of complication

    during the second (22-24 weeks) after ultrasound screening

  • ultrasound signs of complication

    1 day

  • ultrasound signs of complication

    just after delivery

  • presence or not of the volvulus

    1 day

  • +7 more secondary outcomes

Study Arms (1)

Pregnant patients seen for second or third trimester

Foetus with diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings

Other: Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examination

Interventions

Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examinationOTHER

Fetal ultrasound during the second or third trimester Postnatal surgery Post mortem examination

Pregnant patients seen for second or third trimester

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All pregnant women

You may qualify if:

  • postnatal diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings

You may not qualify if:

  • the absence of prenatal imaging assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Volvulus Of Midgut

Interventions

Pregnancy Trimester, ThirdAutopsy

Intervention Hierarchy (Ancestors)

Pregnancy TrimestersReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

October 25, 2017

First Posted

December 5, 2017

Study Start

January 1, 2006

Primary Completion

July 1, 2017

Study Completion

September 30, 2017

Last Updated

December 5, 2017

Record last verified: 2017-10

Locations

FR(1)