Cohort Study on Neuroimmune Diseases in the Reproductive Age

Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Study ID
NCT07653984
Status
Recruiting
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Conditions

  • Autoimmune Encephalitis
  • Guillain-Barré Syndrome (GBS)
  • Multiple Sclerosis
  • Myasthenia Gravis
  • Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
  • Neuromyelitis Optica Spectrum Disorders (NMOSD)

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 55 Years
Healthy Volunteers
Accepted

Study Details

Neuroimmune diseases are more prevalent among women of reproductive age. Studies have shown that neuroimmune diseases may impact fertility. Therefore, effective management of neuroimmune diseases during pregnancy is particularly important. This study included a follow-up period of up to five years in patients with pregnancy-associated neuroimmune disorders. Data collected included relapse frequency, symptomatology, imaging findings, treatment regimens, peripheral blood profiles, EDSS scores, and MRI results. In addition, maternal drug concentrations, postpartum relapse rates, and neonatal development were monitored after delivery. Following the successful completion of the five-year follow-up, the research team plans to continue the prospective epidemiological study with ten-year follow-up phases. The aim of this study is to generate detailed clinical data on pregnancy-associated autoimmune diseases and to equip clinicians with evidence-based strategies for optimizing disease management during the reproductive age.

Key Dates

First listed
Jun 17, 2026
Start date
Apr 21, 2024
Status verified
Nov 2025
Primary completion
Jan 31, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Patient group
    Patient group: Age-matched women with neuroimmune diseases and fertility plans were recruited from the Fertility and Neuroimmune Diseases Multidisciplinary Outpatient Clinic of the Third Affiliated Hospital, Sun Yat-sen University for epidemiological investigation and clinical prospective study.
  • Arm: Healthy control group
    Healthy control group: Age-matched healthy women planning pregnancy were recruited from the Department of Obstetrics at the Third Affiliated Hospital, Sun Yat-sen University for epidemiological and prospective clinical investigation.

Primary Outcome Measure

Annual recurrence rate of neuroimmune diseases [ Time Frame: The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months. ]

Central Contacts

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