Cohort Study on Neuroimmune Diseases in the Reproductive Age

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Cohort Study on Neuroimmune Diseases in the Reproductive Age

ClinicalTrials.gov ID

NCT07653984

Acronym / sponsor ID

RANID / 2024-309-03

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

Study type

Observational

Recruitment status

Recruiting

Enrolment

100 participants (estimated)

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other

Study start

21 Apr 2024 (actual)

Primary completion

Jan 2030 (estimated)

Study completion

Apr 2030 (estimated)

First posted

17 Jun 2026 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

2

Who may qualify

Ages

20 to 55 years

Sex

Female only

Healthy volunteers

Accepted

Age groups

Adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Annual recurrence rate of neuroimmune diseases

   Time frame: 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.

2. Demographic Characteristics

   Time frame: 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.

3. Disease Duration and Initial Attack Status

   Time frame: 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.

4. Lesion Location at Baseline

   Time frame: 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.

5. Visual Acuity and Visual Fields at Baseline

   Time frame: 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.

6. Prevalence of Comorbid Autoimmune Diseases

   Time frame: 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.

7. Maternal complication rates

   Time frame: 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.

8. Obstetrical History: Number of Pregnancies and Miscarriages

   Time frame: 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.

9. Tryptophan derived neurotransmitter levels

   Time frame: 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.

10. Expanded Disability Status Scale (EDSS) Score

    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.

    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.

11. Binocular Visual Acuity Score

    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 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.

12. Ocular Orbital Symmetry Index (OOSI) Score

    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.

    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.

13. Visual Analogue Scale (VAS) for Pain Score

    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.

    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.

14. Functional Form for Ambulatory and Independence Tasks - Fatigue (FFAIT-F) Score

    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.

    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.

15. EuroQol 5-Dimension (EQ-5D) Score

    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.

    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.

16. Modified Rankin Scale (mRS) Score

    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.

    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.

17. Zarit Burden Interview (ZBI) Score

    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.

    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.

18. 36-Item Short Form Survey (SF-36) Score

    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.

    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.

19. Hamilton Anxiety Rating Scale (HAMA) Score

    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.

    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.

20. Hamilton Depression Rating Scale (HAMD) Score

    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.

    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.

21. Activities of Daily Living (ADL) as measured by the Modified Barthel Index

    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.

    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.

22. Mini-Mental State Examination (MMSE) Score

    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.

    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.

23. Montreal Cognitive Assessment (MoCA) Score

    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.

    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.

24. Self-Rating Anxiety Scale (SAS) Score

    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.

    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.

25. Self-Rating Depression Scale (SDS) Score

    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.

    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.

26. Modified Fatigue Impact Scale (MFIS) Score

    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.

    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.

27. Serum Glucose and Blood Pressure

    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.

    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.

28. High-sensitivity C-reactive Protein (hs-CRP) 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.

    Concentration of high-sensitivity C-reactive protein in serum, measured in mg/L, as a marker of systemic inflammation in all participants.

29. Serum Creatinine and Estimated Glomerular Filtration Rate (eGFR)

    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 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.

30. Complete Blood Count (CBC) Parameters

    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.

    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).

31. Lymphocyte Subset Absolute Counts

    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.

    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.

32. Serum Immunoglobulin Levels

    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.

    Concentrations of major immunoglobulin classes (e.g., IgG, IgA, IgM) in serum, measured in g/L, from all participants.

33. Complement System Components

    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 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.

34. Autoantibody and Biomarker Serostatus

    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.

    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).

35. Serum Cytokine and Chemokine Concentrations

    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.

    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.

36. Serum Neurofilament Light Chain (NfL) 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.

    Concentration of neurofilament light chain (NfL) in serum, a biomarker of neuroaxonal injury, measured in pg/mL in all participants.

37. Cerebrospinal Fluid (CSF) Biomarker Concentrations

    Time frame: 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.

38. Satralizumab Concentration in Serum, Cord Blood, and Breast Milk

    Time frame: 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.

39. Number of Participants with New or Enlarging Lesions on Brain and Spinal Cord MRI

    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).

    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.

40. Number of Participants with Optic Nerve Abnormalities on MRI

    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).

    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.

41. Number of Participants with Abnormal Visual Evoked Potentials (VEP)

    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).

    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.

42. Gestational Age at Delivery

    Time frame: 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.

43. Number of Participants by Pregnancy Outcome and Mode of Delivery

    Time frame: 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.

44. Number of Participants Receiving Obstetric Analgesia or Anesthesia

    Time frame: 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.

45. Number of Participants with Intrapartum and Postpartum Complications

    Time frame: 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.

46. Number of Participants Initiating Breastfeeding

    Time frame: 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.

47. Fetal Biometry Measurements: Biparietal Diameter, Head Circumference, Abdominal Circumference, and Femur Length

    Time frame: 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.

48. Estimated Fetal Weight

    Time frame: 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.

49. Umbilical Artery Doppler Pulsatility Index

    Time frame: 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.

50. Amniotic Fluid Volume Index

    Time frame: 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.

51. Number of Participants with Non-Reactive Non-Stress Test

    Time frame: 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.

52. Number of Participants with Pregnancy Loss

    Time frame: 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.

53. Number of Participants with Preterm Birth

    Time frame: 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).

54. Number of Neonates with Growth Restriction

    Time frame: 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.

55. Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)

    Time frame: 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.

56. Number of Neonates with Neonatal Death

    Time frame: 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.

57. Hemoglobin Concentration and Red Blood Cell Count

    Time frame: 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.

58. White Blood Cell and Neutrophil Count

    Time frame: 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.

59. Platelet Count

    Time frame: 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.

60. Apgar score of neonates

    Time frame: 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

61. Weight of neonates

    Time frame: 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

62. Height of neonates

    Time frame: 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

63. Head circumference of neonates

    Time frame: 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

64. Neonatal satralizumab concentrations

    Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
• Background: PubMed 36453174Carra-Dalliere C, Rollot F, Deschamps R, Ciron J, Vukusic S, Audoin B, Ruet A, Maillart E, Papeix C, Zephir H, Laplaud D, Cohen M, Bourre B, El-Bahi I, Labauge P, Casey R, Ayrignac X, Marignier R. Pregnancy and post-partum in patients with myelin-oligodendrocyte glycoprotein antibody-associated disease. Mult Scler. 2023 Feb;29(2):270-276. doi: 10.1177/13524585221134214. Epub 2022 Dec 1.
• Background: PubMed 35938661Longbrake E. Myelin Oligodendrocyte Glycoprotein-Associated Disorders. Continuum (Minneap Minn). 2022 Aug 1;28(4):1171-1193. doi: 10.1212/CON.0000000000001127.
• Background: PubMed 30980491Cobo-Calvo A, Ruiz A, Marignier R. Myelin oligodendrocyte glycoprotein antibody associated disease: about the importance of diagnostic assays and selection of the target population in retrospective studies. Eur J Neurol. 2019 May;26(5):e58-e59. doi: 10.1111/ene.13896. No abstract available.
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• Background: PubMed 27741183Pacheco LD, Saad AF, Hankins GD, Chiosi G, Saade G. Guillain-Barre Syndrome in Pregnancy. Obstet Gynecol. 2016 Nov;128(5):1105-1110. doi: 10.1097/AOG.0000000000001716.
• Background: PubMed 26948435Willison HJ, Jacobs BC, van Doorn PA. Guillain-Barre syndrome. Lancet. 2016 Aug 13;388(10045):717-27. doi: 10.1016/S0140-6736(16)00339-1. Epub 2016 Mar 2.
• Background: PubMed 22825272Magley J, Towner D, Tache V, Apperson ML. Pregnancy outcome in anti-N-methyl-D-aspartate receptor encephalitis. Obstet Gynecol. 2012 Aug;120(2 Pt 2):480-483. doi: 10.1097/AOG.0b013e31825935d4.
• Background: PubMed 29490181Dalmau J, Graus F. Antibody-Mediated Encephalitis. N Engl J Med. 2018 Mar 1;378(9):840-851. doi: 10.1056/NEJMra1708712. No abstract available.
• Background: PubMed 36441535Dalmau J, Graus F. Autoimmune Encephalitis-Misdiagnosis, Misconceptions, and How to Avoid Them. JAMA Neurol. 2023 Jan 1;80(1):12-14. doi: 10.1001/jamaneurol.2022.4154. No abstract available.
• Background: PubMed 33648779Roche P, Bouhour F. Myasthenia gravis and pregnancy. Rev Neurol (Paris). 2021 Mar;177(3):215-219. doi: 10.1016/j.neurol.2020.09.015. Epub 2021 Feb 26.
• Background: PubMed 29655454Hamel J, Ciafaloni E. An Update: Myasthenia Gravis and Pregnancy. Neurol Clin. 2018 May;36(2):355-365. doi: 10.1016/j.ncl.2018.01.005.
• Background: PubMed 35065040Punga AR, Maddison P, Heckmann JM, Guptill JT, Evoli A. Epidemiology, diagnostics, and biomarkers of autoimmune neuromuscular junction disorders. Lancet Neurol. 2022 Feb;21(2):176-188. doi: 10.1016/S1474-4422(21)00297-0.
• Individual participant dataSharing planned: No

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