跳至主要内容
临床试验/NCT07653984
NCT07653984招募中不适用

Cohort Study on Neuroimmune Diseases in the Reproductive Age

Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
Third Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei Qiu

Chief Physician

Third Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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