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.
Study Type
OBSERVATIONAL
Enrollment
100
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGAnnual recurrence rate of neuroimmune diseases
To assess the effect of pregnancy on disease activity of neuroimmune disorders by measuring annual relapse rates of neuroimmune disorders at three different time periods, from enrollment to preparation for pregnancy, pregnancy, and postpartum.
Time frame: The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
Demographic Characteristics
Measurement of demographic characteristics of enrolled neuroimmune disease patients and healthy controls to obtain baseline data for both populations.
Time frame: The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
Disease Duration and Initial Attack Status
Collection and recording of disease duration (in years from initial diagnosis to present) and whether it is the first episode (Yes/No) in patients with neuroimmune diseases. Data sourced from patient medical records and baseline interviews.
Time frame: Assessed immediately from the time of enrollment for a maximum of 1 week.
Lesion Location at Baseline
Assessment and recording of the anatomical location of the initial or primary lesion via brain and/or spinal cord Magnetic Resonance Imaging (MRI) performed at enrollment. Location will be described by a radiologist or neurologist using standard neuroanatomical terminology.
Time frame: Assessed immediately from the date of enrollment, up to 1 week.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: The assessment period is 5 and 26 days after delivery, up to a maximum of 1 month.
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