RecruitingNCT07653984

Cohort Study on Neuroimmune Diseases in the Reproductive Age


Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Enrollment

100 participants

Start Date

Apr 21, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 55 Years

Inclusion Criteria9

  • Patient Group: A total of fifty participants are expected to be enrolled.
  • Women aged 20-55 years with childbearing potential.
  • Voluntary informed consent.
  • Availability of complete personal information.
  • A confirmed diagnosis of neuromyelitis optica spectrum disorder (NMOSD), multiple sclerosis (MS), autoimmune encephalitis, myasthenia gravis, Guillain-Barré syndrome, or myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).
  • Healthy Control Group: A total of fifty healthy women are expected to be included.
  • Age- and sex-matched women of childbearing age with plans for pregnancy
  • Voluntary informed consent.
  • Availability of complete personal information.

Exclusion Criteria8

  • Patient Group:
  • Patients with an undetermined or unconfirmed diagnosis.
  • Incomplete personal information that cannot be obtained through follow-up.
  • Participants who voluntarily withdrew from the study and revoked informed consent.
  • Healthy Control Group:
  • Individuals diagnosed with neuroimmune-related disorders.
  • Incomplete personal information that cannot be obtained through follow-up.
  • Participants who voluntarily withdrew from the study and revoked informed consent.

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Locations(1)

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT07653984


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