About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Individuals diagnosed with neuroimmune-related disorders.
Trial population
The project aims to recruit women with neuroimmune diseases who are planning to conceive, starting on March 21, 2024. These participants will be enrolled through the Multidisciplinary Outpatient Clinic for Fertility and Neuroimmune Diseases at the Third Affiliated Hospital, Sun Yat-sen University for an epidemiological survey and prospective clinical study. Age-matched healthy women planning pregnancy will be recruited from the Department of Obstetrics at the Third Affiliated Hospital, Sun Yat-sen University to serve as healthy controls for the epidemiological and prospective clinical study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Annual recurrence rate of neuroimmune diseases
To assess the effect of pregnancy on disease activity of neuroimmune disorders by measuring annual relapse rates of neuroimmune disorders at three different time periods, from enrollment to preparation for pregnancy, pregnancy, and postpartum.
Demographic Characteristics
Measurement of demographic characteristics of enrolled neuroimmune disease patients and healthy controls to obtain baseline data for both populations.
Disease Duration and Initial Attack Status
Collection and recording of disease duration (in years from initial diagnosis to present) and whether it is the first episode (Yes/No) in patients with neuroimmune diseases. Data sourced from patient medical records and baseline interviews.
Lesion Location at Baseline
Assessment and recording of the anatomical location of the initial or primary lesion via brain and/or spinal cord Magnetic Resonance Imaging (MRI) performed at enrollment. Location will be described by a radiologist or neurologist using standard neuroanatomical terminology.
Sponsors and contacts
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