Cohort Study on Neuroimmune Diseases in the Reproductive Age

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-55
SponsorThird Affiliated Hospital, Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Patient group
Group B: Healthy control group

Trial outcomes

Primary outcomes

1

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.

Time frame
The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
2

Demographic Characteristics

Measurement of demographic characteristics of enrolled neuroimmune disease patients and healthy controls to obtain baseline data for both populations.

Time frame
The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
3

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.

Time frame
Assessed immediately from the time of enrollment for a maximum of 1 week.
4

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.

Time frame
Assessed immediately from the date of enrollment, up to 1 week.

Secondary outcomes

Other outcomes

Sponsors and contacts

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