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Clinical Trials/NCT07653984
NCT07653984RecruitingNot Applicable

Cohort Study on Neuroimmune Diseases in the Reproductive Age

Third Affiliated Hospital, Sun Yat-Sen University1 site in 1 country100 target enrollmentStarted: April 21, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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 Criteria

  • 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.

Investigators

Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wei Qiu

Chief Physician

Third Affiliated Hospital, Sun Yat-Sen University

Study Sites (1)

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