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Cohort Study on Neuroimmune Diseases in the Reproductive Age (RANID)

13 giugno 2026 aggiornato da: Wei Qiu, Third Affiliated Hospital, Sun Yat-Sen University
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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510630
        • Reclutamento
        • The Third Affiliated Hospital, Sun Yat-sen University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

Inclusion Criteria:

  • Patient Group: A total of fifty participants are expected to be enrolled.

    1. Women aged 20-55 years with childbearing potential.
    2. Voluntary informed consent.
    3. Availability of complete personal information.
    4. 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.

  1. Age- and sex-matched women of childbearing age with plans for pregnancy
  2. Voluntary informed consent.
  3. Availability of complete personal information.

Exclusion Criteria:

  • Patient Group:

    1. Patients with an undetermined or unconfirmed diagnosis.
    2. Incomplete personal information that cannot be obtained through follow-up.
    3. Participants who voluntarily withdrew from the study and revoked informed consent.

Healthy Control Group:

  1. Individuals diagnosed with neuroimmune-related disorders.
  2. Incomplete personal information that cannot be obtained through follow-up.
  3. Participants who voluntarily withdrew from the study and revoked informed consent.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Patient group
Patient group: Age-matched women with neuroimmune diseases and fertility plans were recruited from the Fertility and Neuroimmune Diseases Multidisciplinary Outpatient Clinic of the Third Affiliated Hospital, Sun Yat-sen University for epidemiological investigation and clinical prospective study.
Healthy control group
Healthy control group: Age-matched healthy women planning pregnancy were recruited from the Department of Obstetrics at the Third Affiliated Hospital, Sun Yat-sen University for epidemiological and prospective clinical investigation.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Annual recurrence rate of neuroimmune diseases
Lasso di tempo: The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
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.
The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
Demographic Characteristics
Lasso di tempo: The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
Measurement of demographic characteristics of enrolled neuroimmune disease patients and healthy controls to obtain baseline data for both populations.
The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
Disease Duration and Initial Attack Status
Lasso di tempo: Assessed immediately from the time of enrollment for a maximum of 1 week.
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.
Assessed immediately from the time of enrollment for a maximum of 1 week.
Lesion Location at Baseline
Lasso di tempo: Assessed immediately from the date of enrollment, up to 1 week.
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.
Assessed immediately from the date of enrollment, up to 1 week.
Visual Acuity and Visual Fields at Baseline
Lasso di tempo: Assessed immediately from the date of enrollment, up to 1 week.
Best-corrected visual acuity assessed at enrollment using a standard Snellen chart, recorded as decimal acuity. Visual fields are assessed concurrently using automated static perimetry, with results expressed as mean deviation.
Assessed immediately from the date of enrollment, up to 1 week.
Prevalence of Comorbid Autoimmune Diseases
Lasso di tempo: Assessed immediately from the date of enrollment, up to 1 week.
Documentation of the presence of other diagnosed autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, thyroiditis) via patient self-reported medical history and review of medical records at enrollment. The outcome will be reported as the number and proportion of participants with at least one comorbid autoimmune disease.
Assessed immediately from the date of enrollment, up to 1 week.
Maternal complication rates
Lasso di tempo: The assessment period is the gestation period of the pregnant woman, up to a maximum of 12 months.
Maternal complication rates were compared between patients with neuroimmune disorders and healthy pregnant controls during early, mid, and late pregnancy: e.g., miscarriage, hyperemesis gravidarum, hypertensive disorders of pregnancy, gestational diabetes mellitus, preeclampsia, eclampsia, infections, and infusion-related reactions.
The assessment period is the gestation period of the pregnant woman, up to a maximum of 12 months.
Obstetrical History: Number of Pregnancies and Miscarriages
Lasso di tempo: Assessed immediately from the date of enrollment, up to 1 week.
Collection of obstetrical history for all female participants via a structured baseline questionnaire, including the total number of pregnancies (including live births, miscarriages, induced abortions, and ectopic pregnancies) and the number of spontaneous miscarriages. Results will be reported as separate count values.
Assessed immediately from the date of enrollment, up to 1 week.
Tryptophan derived neurotransmitter levels
Lasso di tempo: The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
Tryptophan-derived neurotransmitter levels were measured in patients with neuroimmune disorders and healthy controls at three different time points: preparation for pregnancy, pregnancy, and postpartum.Tryptophan-derived neurotransmitter levels included the following:kynurenine, xanthuric acid, tyramine, tryptamine, DL-3- methoxyadrenaline hydrochloride, homovanillic acid, acetylcholine, choline, phenylpyruvic acid, betaine, dopamine, peak shojic acid, vermilion arginate, 3-hydroxybenzoic acid, and vermilion arginate, 3-hydroxy-2-aminobenzoic acid, 3-hydroxy-DL-kynurenine, 5-hydroxytryptophan, y-aminobutyric acid, epinephrine, noradrenaline, histamine, vanillylmandelic acid, serotonin, etc.
The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
Expanded Disability Status Scale (EDSS) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The EDSS is a standardized method of quantifying disability in neurological disorders, primarily multiple sclerosis. Scores range from 0.0 (normal neurological examination) to 10.0 (death due to the disease). A higher score indicates a worse outcome. All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Binocular Visual Acuity Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Visual acuity is assessed for both eyes together (binocularly) using a standardized Snellen chart. The result is recorded as a decimal score (e.g., 1.0, 0.5). A higher score indicates a better outcome (sharper vision). All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Ocular Orbital Symmetry Index (OOSI) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The OOSI is a quantitative measure of orbital and ocular symmetry, potentially used in conditions like thyroid eye disease. The score is derived from imaging measurements. A lower score typically indicates a better outcome (greater symmetry), but the specific interpretation should be provided based on the scoring system's manual. All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Visual Analogue Scale (VAS) for Pain Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The VAS is a unidimensional measure of pain intensity. Participants mark their pain level on a 100-mm horizontal line, ranging from "No pain" (0 mm) to "Worst pain imaginable" (100 mm). A higher score indicates a worse outcome. All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Functional Form for Ambulatory and Independence Tasks - Fatigue (FFAIT-F) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The FFAIT-F assesses the impact of fatigue on ambulation and activities of daily living. The total score typically ranges from 0 to a defined maximum, with specific ranges for subscales. A higher score indicates a worse outcome (greater fatigue impact). All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
EuroQol 5-Dimension (EQ-5D) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The EQ-5D is a standardized instrument for measuring generic health status. It comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The index value score typically ranges from less than 0 (health states worse than death) to 1.0 (perfect health). A higher score indicates a better outcome. All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Modified Rankin Scale (mRS) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The mRS is a clinician-reported measure of global disability, commonly used in stroke and other neurological disorders. It is a single-digit ordinal scale ranging from 0 (no symptoms) to 6 (death). A higher score indicates a worse outcome. All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Zarit Burden Interview (ZBI) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The ZBI is a self-report measure assessing the perceived burden of caregivers. The total score ranges from 0 to 88, with higher scores representing a greater sense of burden. A higher score indicates a worse outcome. All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
36-Item Short Form Survey (SF-36) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The SF-36 is a patient-reported survey of health-related quality of life. It yields scores for eight domains, each typically scaled from 0 to 100. For all domains, a higher score indicates a better outcome. All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Hamilton Anxiety Rating Scale (HAMA) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The HAMA is a clinician-rated scale to measure the severity of anxiety symptoms. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety. A higher score indicates a worse outcome. All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Hamilton Depression Rating Scale (HAMD) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The HAMD is a clinician-rated scale to measure the severity of depressive symptoms. The score range depends on the version (e.g., 17-item HAMD ranges from 0 to 52). A higher score indicates a worse outcome (more severe depression). All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Activities of Daily Living (ADL) as measured by the Modified Barthel Index
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The Modified Barthel Index measures a person's ability to perform basic activities of daily living independently. The total score typically ranges from 0 (fully dependent) to 100 (fully independent). A higher score indicates a better outcome. All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Mini-Mental State Examination (MMSE) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The MMSE is a brief 30-point questionnaire used to screen for cognitive impairment. Scores range from 0 to 30. A higher score indicates a better outcome (less cognitive impairment). All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Montreal Cognitive Assessment (MoCA) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The MoCA is a cognitive screening test designed to detect mild cognitive impairment. The total score ranges from 0 to 30. A higher score indicates a better outcome. All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Self-Rating Anxiety Scale (SAS) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The SAS is a self-report questionnaire assessing anxiety symptoms. The raw score (typically 20-80) is often converted to an index. A higher score indicates a worse outcome (more severe anxiety). All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Self-Rating Depression Scale (SDS) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The SDS is a self-report questionnaire assessing depressive symptoms. The raw score (typically 20-80) is often converted to an index. A higher score indicates a worse outcome (more severe depression). All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Modified Fatigue Impact Scale (MFIS) Score
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
The MFIS is a 21-item questionnaire assessing the impact of fatigue on physical, cognitive, and psychosocial functioning. The total score ranges from 0 to 84. A higher score indicates a worse outcome (greater impact of fatigue). All participants (patients and controls) will complete this survey.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Serum Glucose and Blood Pressure
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Fasting serum glucose concentration (measured in mmol/L or mg/dL) and systolic/diastolic blood pressure (measured in mmHg) are assessed in all participants (patients and healthy controls) at each timepoint.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
High-sensitivity C-reactive Protein (hs-CRP) Concentration
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Concentration of high-sensitivity C-reactive protein in serum, measured in mg/L, as a marker of systemic inflammation in all participants.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Serum Creatinine and Estimated Glomerular Filtration Rate (eGFR)
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Serum creatinine concentration (measured in μmol/L or mg/dL) and the estimated Glomerular Filtration Rate (eGFR, calculated in mL/min/1.73m²) are assessed to monitor renal function in all participants.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Complete Blood Count (CBC) Parameters
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Absolute counts of blood cells, including neutrophils, lymphocytes, and eosinophils, measured in cells/μL from peripheral blood samples of all participants (patients and healthy controls).
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Lymphocyte Subset Absolute Counts
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Absolute counts (cells/μL) of specific lymphocyte subsets in peripheral blood, including B cells, NK cells, T helper cells (Th), Th17 cells, and cytotoxic T cells, measured by flow cytometry in all participants.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Serum Immunoglobulin Levels
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Concentrations of major immunoglobulin classes (e.g., IgG, IgA, IgM) in serum, measured in g/L, from all participants.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Complement System Components
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Serum concentrations of complement components C3, C4, and C5 (measured in g/L or U/mL) and the complement activation marker sC5b-9 (measured in ng/mL) in all participants.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Autoantibody and Biomarker Serostatus
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Seropositivity rates and titers for specific autoantibodies and biomarkers, including anti-AQP4 IgG, and GFAP, measured in serum from all participants. Results may be reported as categorical (positive/negative) and/or continuous (titer or concentration).
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Serum Cytokine and Chemokine Concentrations
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Concentrations (typically in pg/mL) of a panel of pro-inflammatory and anti-inflammatory cytokines and chemokines (including IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17, IFN-α, IFN-γ, TNF-α) in serum from all participants, measured by multiplex immunoassay.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Serum Neurofilament Light Chain (NfL) Concentration
Lasso di tempo: Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Concentration of neurofilament light chain (NfL) in serum, a biomarker of neuroaxonal injury, measured in pg/mL in all participants.
Assessed at seven timepoints: pre-pregnancy (baseline), during pregnancy (first trimester, second trimester, third trimester), and postpartum (at 3, 6, and 12 months post-delivery). The total assessment period spans from enrollment up to 25 months.
Cerebrospinal Fluid (CSF) Biomarker Concentrations
Lasso di tempo: Timepoints for CSF collection are based on clinical necessity and may not align with the standard schedule.
Concentrations of biomarkers in cerebrospinal fluid, including IL-6, CXCL13, and S100B (measured in pg/mL), assessed in a subset of patients with neuroimmune diseases who undergo lumbar puncture for clinical reasons. This assessment is typically performed in the patient group only.
Timepoints for CSF collection are based on clinical necessity and may not align with the standard schedule.
Satralizumab Concentration in Serum, Cord Blood, and Breast Milk
Lasso di tempo: Postpartum days 5 and 26.
Concentration of satralizumab (measured in μg/mL) in maternal serum, cord blood, and breast milk. Samples are collected at specific postpartum timepoints (e.g., day 5 and day 26). This pharmacokinetic assessment is performed only in patients treated with satralizumab.
Postpartum days 5 and 26.
Number of Participants with New or Enlarging Lesions on Brain and Spinal Cord MRI
Lasso di tempo: The assessment period spans from enrollment up to 25 months, covering pre-pregnancy, pregnancy (trimester 1, 2, and 3), and postpartum (up to 12 months).
The presence of new or enlarging hyperintense lesions on MRI scans of the brain and spinal cord will be assessed by a blinded neuroradiologist. This outcome measures radiological disease activity by reporting the number and percentage of participants exhibiting at least one new or enlarging lesion compared to the previous scan.
The assessment period spans from enrollment up to 25 months, covering pre-pregnancy, pregnancy (trimester 1, 2, and 3), and postpartum (up to 12 months).
Number of Participants with Optic Nerve Abnormalities on MRI
Lasso di tempo: The assessment period spans from enrollment up to 25 months, covering pre-pregnancy, pregnancy (trimester 1, 2, and 3), and postpartum (up to 12 months).
MRI scans of the optic nerves will be assessed for signs of inflammation or atrophy (e.g., T2 hyperintensity, contrast enhancement, nerve thickening or thinning). The outcome will be reported as the number and percentage of participants with qualitative MRI abnormalities of the optic nerves at each timepoint.
The assessment period spans from enrollment up to 25 months, covering pre-pregnancy, pregnancy (trimester 1, 2, and 3), and postpartum (up to 12 months).
Number of Participants with Abnormal Visual Evoked Potentials (VEP)
Lasso di tempo: The assessment period spans from enrollment up to 25 months, covering pre-pregnancy, pregnancy (trimester 1, 2, and 3), and postpartum (up to 12 months).
Visual Evoked Potentials will be performed to assess the functional integrity of the visual pathways. The outcome will be reported as the number and percentage of participants with abnormal VEP findings (e.g., prolonged P100 latency) at each assessment timepoint.
The assessment period spans from enrollment up to 25 months, covering pre-pregnancy, pregnancy (trimester 1, 2, and 3), and postpartum (up to 12 months).
Gestational Age at Delivery
Lasso di tempo: The assessment period covers the delivery hospitalization, up to 2 days.
Gestational age at the time of delivery, measured in completed weeks. This is a continuous variable that will be reported and compared between the patient and control groups.
The assessment period covers the delivery hospitalization, up to 2 days.
Number of Participants by Pregnancy Outcome and Mode of Delivery
Lasso di tempo: The assessment period covers the delivery hospitalization, up to 2 days.
The outcome of pregnancy (e.g., live birth, stillbirth) and the mode of delivery (e.g, spontaneous vaginal delivery, operative vaginal delivery, cesarean section) will be recorded. The results will be reported as the number and percentage of participants in each category, stratified by patient and control groups.
The assessment period covers the delivery hospitalization, up to 2 days.
Number of Participants Receiving Obstetric Analgesia or Anesthesia
Lasso di tempo: The assessment period covers the delivery hospitalization, up to 2 days.
The utilization of any form of obstetric analgesia or anesthesia during labor and delivery (e.g., epidural, spinal) will be documented. The outcome will be reported as the number and percentage of participants who received analgesic or anesthetic intervention.
The assessment period covers the delivery hospitalization, up to 2 days.
Number of Participants with Intrapartum and Postpartum Complications
Lasso di tempo: The assessment period covers the delivery hospitalization, up to 3 months.
The occurrence of specified intrapartum and postpartum complications (e.g., postpartum hemorrhage, perineal laceration, pre-eclampsia, postpartum infection) will be recorded. The outcome will be reported as the number and percentage of participants experiencing each type of complication.
The assessment period covers the delivery hospitalization, up to 3 months.
Number of Participants Initiating Breastfeeding
Lasso di tempo: The assessment period covers the delivery hospitalization, up to 1 month.
The initiation of breastfeeding (defined as any attempt to breastfeed the newborn after delivery) will be documented prior to hospital discharge. The outcome will be reported as the number and percentage of participants who initiated breastfeeding.
The assessment period covers the delivery hospitalization, up to 1 month.
Fetal Biometry Measurements: Biparietal Diameter, Head Circumference, Abdominal Circumference, and Femur Length
Lasso di tempo: Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
Standard fetal biometric parameters, including Biparietal Diameter (BPD), Head Circumference (HC), Abdominal Circumference (AC), and Femur Length (FL), are measured via prenatal ultrasound. These measurements (reported in millimeters) are used to monitor fetal growth and estimate gestational age. The values will be reported as Z-scores or percentiles for each trimester, and compared between groups.
Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
Estimated Fetal Weight
Lasso di tempo: Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
The fetal weight is estimated (in grams) using a formula that incorporates standard biometric measurements (e.g., BPD, HC, AC, FL) from prenatal ultrasound. The estimated fetal weight (EFW) percentile for gestational age will be calculated and reported for each trimester, and compared between groups.
Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
Umbilical Artery Doppler Pulsatility Index
Lasso di tempo: Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
The Umbilical Artery Pulsatility Index (UA-PI) is measured via Doppler ultrasound as an indicator of placental vascular resistance. The value is a dimensionless ratio. Results will be reported as the mean PI value and/or the number of participants with abnormal (e.g., absent or reversed end-diastolic flow) Doppler findings in each group.
Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
Amniotic Fluid Volume Index
Lasso di tempo: Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
The amniotic fluid volume is assessed via ultrasound, typically measured as the Amniotic Fluid Index (AFI) in centimeters. The result will be reported as the AFI value for each trimester, and the number of participants with oligohydramnios (abnormally low fluid) or polyhydramnios (abnormally high fluid) will be documented and compared between groups.
Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
Number of Participants with Non-Reactive Non-Stress Test
Lasso di tempo: Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
In the third trimester, fetal well-being may be assessed by a Non-Stress Test (NST). The outcome is reported as the number and percentage of participants with a non-reactive NST, which may indicate potential fetal compromise, and compared between groups.
Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
Number of Participants with Pregnancy Loss
Lasso di tempo: Assessed at the time of delivery hospitalization.
The number and percentage of participants experiencing pregnancy loss, categorized as miscarriage (pregnancy loss at <20 weeks gestation) or stillbirth (fetal death at ≥20 weeks gestation). This outcome compares the rates of pregnancy loss between mothers with neuroimmune diseases and healthy controls.
Assessed at the time of delivery hospitalization.
Number of Participants with Preterm Birth
Lasso di tempo: Assessed at the time of delivery.
The number and percentage of participants who deliver prematurely (at a gestational age of less than 37 completed weeks).
Assessed at the time of delivery.
Number of Neonates with Growth Restriction
Lasso di tempo: Assessed at the time of birth.
The number and percentage of neonates born with a birth weight below the 10th percentile for their gestational age and sex (small for gestational age, SGA). This outcome reports the rate of fetal growth restriction.
Assessed at the time of birth.
Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)
Lasso di tempo: Assessed from birth to hospital discharge, up to 1 month.
The number and percentage of neonates requiring admission to the NICU for any reason after birth. This outcome measures the rate of significant neonatal morbidity.
Assessed from birth to hospital discharge, up to 1 month.
Number of Neonates with Neonatal Death
Lasso di tempo: Assessed from birth to 28 days of life.
The number and percentage of neonates who die within the first 28 days of life. This outcome reports the neonatal mortality rate.
Assessed from birth to 28 days of life.
Hemoglobin Concentration and Red Blood Cell Count
Lasso di tempo: Assessed at 1 day after birth.
Hemoglobin concentration (measured in g/dL) and red blood cell count (measured in 10¹²/L) are assessed from neonatal complete blood count. These values will be reported as continuous measures and compared between neonates born to mothers with neuroimmune diseases and those born to healthy controls. The number of neonates with anemia (hemoglobin below the reference range for gestational and postnatal age) will also be reported.
Assessed at 1 day after birth.
White Blood Cell and Neutrophil Count
Lasso di tempo: Assessed at 1 day after birth.
The absolute count of total white blood cells and neutrophils (measured in 10⁹/L) are assessed from neonatal complete blood count. These values will be reported as continuous measures and compared between the two groups. The number of neonates with neutropenia (neutrophil count below the reference range) will also be reported.
Assessed at 1 day after birth.
Platelet Count
Lasso di tempo: Assessed at 1 day after birth.
The absolute platelet count (measured in 10⁹/L) is assessed from neonatal complete blood count. This value will be reported as a continuous measure and compared between the two groups. The number of neonates with thrombocytopenia will also be reported.
Assessed at 1 day after birth.
Apgar score of neonates
Lasso di tempo: The assessment period is up to 1 day after delivery of the fetus.
Apgar score of neonates born to mothers with neuroimmune disorders and healthy pregnant controls were compared at the same postpartum time points
The assessment period is up to 1 day after delivery of the fetus.
Weight of neonates
Lasso di tempo: The assessment period is up to 1 day after delivery of the fetus.
Weight of neonates born to mothers with neuroimmune disorders and healthy pregnant controls were compared at the same postpartum time points
The assessment period is up to 1 day after delivery of the fetus.
Height of neonates
Lasso di tempo: The assessment period is up to 1 day after delivery of the fetus.
Height of neonates born to mothers with neuroimmune disorders and healthy pregnant controls were compared at the same postpartum time points
The assessment period is up to 1 day after delivery of the fetus.
Head circumference of neonates
Lasso di tempo: The assessment period is up to 1 day after delivery of the fetus.
Head circumference of neonates born to mothers with neuroimmune disorders and healthy pregnant controls were compared at the same postpartum time points
The assessment period is up to 1 day after delivery of the fetus.
Neonatal satralizumab concentrations
Lasso di tempo: The assessment period is 5 and 26 days after delivery, up to a maximum of 1 month.
Collection of satralizumab concentrations in the serum of newborns born to mothers with neuroimmune diseases on postnatal days 5 and 26.
The assessment period is 5 and 26 days after delivery, up to a maximum of 1 month.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 aprile 2024

Completamento primario (Stimato)

1 gennaio 2030

Completamento dello studio (Stimato)

1 aprile 2030

Date di iscrizione allo studio

Primo inviato

28 aprile 2025

Primo inviato che soddisfa i criteri di controllo qualità

13 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 giugno 2026

Ultimo verificato

1 novembre 2025

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2024-309-03

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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