Cohort Study on Neuroimmune Diseases in the Reproductive Age
Recruiting · NCT07653984 · Observational (researchers observe without assigning treatment) · Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- The Third Affiliated Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China