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NCT02956824: MISIA

Incidence of MRI Sacro-Iliac Joint Anomalies in Young Women

Completed NA Last updated 30 May 2024
What this trial tests

NA trial testing Standard care in Women (Between 18 to 50 Years Old) in 512 participants. Completed in 27 May 2019.

Timeline
16 November 2015
Primary endpoint
27 May 2019
27 May 2019

Quick facts

Lead sponsorUniversity Hospital, Montpellier
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment512
Start date16 November 2015
Primary completion27 May 2019
Estimated completion27 May 2019
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Montpellier

Who can join

Adults 18 to 50, female only, with Women (Between 18 to 50 Years Old) or Sacro-iliac Joints. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prospective multicenter study assessing the incidence of inflammatory and structural lesions seen on MRI of the SI joints in a consecutive population of women aged 18-50 years old. The study hypothesis is SpA may be misdiagnosed on MRI in post partum women due to increased stress on the joint following pregnancy and childbirth, as MRI of the SI joints may show lesions that could mimics axial spondyloarthritis. The primary objective of this study is to determine the incidence of SI lesions seen at MRI in women. The secondary objectives are to compare the incidence and pattern of MRI inflammatory and structural lesions of the SI joints and to determine the factors associated with inflammatory or structural changes of the SI joints in a population of women. the investigators will especially compare the population of women within a year after childbirth versus the population of women who never gave birth or who gave birth over 24 months ago or more.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. MRI of sacroiliac joints for the diagnosis of axial SpA: prevalence of inflammatory and structural lesions in nulliparous, early postpartum and late postpartum women.
    Hoballah A, Lukas C, Leplat C, Taourel P, et al · · 2020 · cited 33× · PMID 32522743 · DOI 10.1136/annrheumdis-2020-217208

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