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.
Age range
20 Years – 55 Years
Sex
FEMALE
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Annual recurrence rate of neuroimmune diseases
Timeframe: The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
Demographic Characteristics
Timeframe: 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
Timeframe: Assessed immediately from the time of enrollment for a maximum of 1 week.
Lesion Location at Baseline
Timeframe: Assessed immediately from the date of enrollment, up to 1 week.
Visual Acuity and Visual Fields at Baseline
Timeframe: Assessed immediately from the date of enrollment, up to 1 week.
Prevalence of Comorbid Autoimmune Diseases
Timeframe: Assessed immediately from the date of enrollment, up to 1 week.
Maternal complication rates
Timeframe: 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
Timeframe: Assessed immediately from the date of enrollment, up to 1 week.
Tryptophan derived neurotransmitter levels
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Postpartum days 5 and 26.
Number of Participants with New or Enlarging Lesions on Brain and Spinal Cord MRI
Timeframe: 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
Timeframe: 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)
Timeframe: 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
Timeframe: The assessment period covers the delivery hospitalization, up to 2 days.
Number of Participants by Pregnancy Outcome and Mode of Delivery
Timeframe: The assessment period covers the delivery hospitalization, up to 2 days.
Number of Participants Receiving Obstetric Analgesia or Anesthesia
Timeframe: The assessment period covers the delivery hospitalization, up to 2 days.
Number of Participants with Intrapartum and Postpartum Complications
Timeframe: The assessment period covers the delivery hospitalization, up to 3 months.
Number of Participants Initiating Breastfeeding
Timeframe: The assessment period covers the delivery hospitalization, up to 1 month.
Fetal Biometry Measurements: Biparietal Diameter, Head Circumference, Abdominal Circumference, and Femur Length
Timeframe: Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
Estimated Fetal Weight
Timeframe: Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
Umbilical Artery Doppler Pulsatility Index
Timeframe: Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
Amniotic Fluid Volume Index
Timeframe: 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
Timeframe: Assessed during the first trimester, second trimester, and third trimester of pregnancy. Up to 10 months.
Number of Participants with Pregnancy Loss
Timeframe: Assessed at the time of delivery hospitalization.
Number of Participants with Preterm Birth
Timeframe: Assessed at the time of delivery.
Number of Neonates with Growth Restriction
Timeframe: Assessed at the time of birth.
Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)
Timeframe: Assessed from birth to hospital discharge, up to 1 month.
Number of Neonates with Neonatal Death
Timeframe: Assessed from birth to 28 days of life.
Hemoglobin Concentration and Red Blood Cell Count
Timeframe: Assessed at 1 day after birth.
White Blood Cell and Neutrophil Count
Timeframe: Assessed at 1 day after birth.
Platelet Count
Timeframe: Assessed at 1 day after birth.
Apgar score of neonates
Timeframe: The assessment period is up to 1 day after delivery of the fetus.
Weight of neonates
Timeframe: The assessment period is up to 1 day after delivery of the fetus.
Height of neonates
Timeframe: The assessment period is up to 1 day after delivery of the fetus.
Head circumference of neonates
Timeframe: The assessment period is up to 1 day after delivery of the fetus.
Neonatal satralizumab concentrations
Timeframe: The assessment period is 5 and 26 days after delivery, up to a maximum of 1 month.