NCT02956824

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
512

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

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

November 16, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2019

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

3.5 years

First QC Date

August 1, 2016

Last Update Submit

May 28, 2024

Conditions

Women (Between 18 to 50 Years Old)Sacro-iliac JointsInflammatory LesionsStructural LesionsAxial Spondyloarthritis

Keywords

Magnetic Resonance Imaging (MRI)Sacro-iliac jointsPelvisErosionFat depositSubchondral sclerosisBone marrow edemaAxial spondyloarthritis

Outcome Measures

Primary Outcomes (1)

  • Presence of MRI inflammatory and structural lesions of the sacroiliac joints (including pubic symphysis) in the population of women who gave birth within the past 12 months.

    MRI Lesions will be analyzed according to ASAS criteria. Inflammatory lesions will be evaluated on STIR (or T2 fat sat or T2 dixon) sequences. Structural lesions will be evaluated on T1 weighted sequences

    Time of MRI (within the year following childbirth or pregnancy)

Secondary Outcomes (2)

  • Morphological analysis of sacroiliac lesions in women aged from 18-50 years old.

    Time of MRI

  • Topographical analysis of sacroiliac lesions in women aged from 18-50 years old.

    Time of MRI

Interventions

Standard careOTHER

Current care

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18 to 50 years old
  • MRI of the pelvis requested as part of an exploration of a gynecological or pelvic pathology
  • Women who delivered within the year OR women who never gave birth or gave birth 24 months ago and over

You may not qualify if:

  • Patients with a personal or family history of inflammatory disease (SpA , ulcerative colitis , chron , PSO , RA, SAPHO)
  • Patients with a history of trauma or surgery of the pelvis
  • Pregnant women
  • Women who gave birth over a year ago and less than 2 years ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Medical Imaging

Montpellier, 34295, France

Location

Related Publications (1)

  • Hoballah A, Lukas C, Leplat C, Taourel P, Pialat JB, Sans N, Ramos-Pascual S, Cyteval C. MRI of sacroiliac joints for the diagnosis of axial SpA: prevalence of inflammatory and structural lesions in nulliparous, early postpartum and late postpartum women. Ann Rheum Dis. 2020 Aug;79(8):1063-1069. doi: 10.1136/annrheumdis-2020-217208. Epub 2020 Jun 10.

    PMID: 32522743DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Catherine CYTEVAL

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

November 7, 2016

Study Start

November 16, 2015

Primary Completion

May 27, 2019

Study Completion

May 27, 2019

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

FR(1)