Cohort Study on Neuroimmune Diseases in the Reproductive Age

NCT07653984 | Recruiting DMC

• 1 other identifier: 2024-309-03
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromyelitis Optica Spectrum Disorders (NMOSD); Multiple Sclerosis; Autoimmune Encephalitis; Myasthenia Gravis; Guillain-Barré Syndrome (GBS); Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Keywords

Neuromyelitis optica spectrum disorders (NMOSD); Multiple Sclerosis; Autoimmune encephalitis; myasthenia gravis; Guillain-Barré Syndrome (GBS); Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD); reproductive age; cohort study

Outcome Measures

Primary Outcomes (64)

• 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.

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

• Demographic Characteristics

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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)

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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)

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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)

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (31)

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Biospecimen

Retention: SAMPLES WITH DNA

blood sample, cerebrospinal fluid, placental tissue, magnetic resonance imaging (MRI)

MeSH Terms

Conditions

Neuromyelitis Optica; Multiple Sclerosis; Autoimmune Diseases of the Nervous System; Myasthenia Gravis; Guillain-Barre Syndrome; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Polyradiculoneuropathy; Polyneuropathies; Peripheral Nervous System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wei Qiu, Ph.D

CONTACT

15899968330; qiuwei120@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: June 17, 2026
• Study Start: April 21, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: June 17, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)