Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA)

Changes in maternal disease activity will be assessed using the Expanded Disability Status Scale (EDSS) for individuals with multiple sclerosis (scored from 0 to 10, with higher scores indicating greater disability). Data will be collected via medical record review and participant self-report questionnaires.

Changes in maternal disease activity will be assessed using magnetic resonance imaging (MRI) findings, including gadolinium-enhancing lesions, new or enlarging T2 lesions, and brain atrophy. Data will be collected via medical record review.

The maternal disease treatment course will be evaluated through an assessment of Disease Modifying Therapy (DMT) used pre-pregnancy to postpartum. This includes the specific type of DMT used in the pre-pregnancy period, any modifications or discontinuation of therapy during pregnancy, and the resumption or initiation of DMTs in the postpartum period. Data will be obtained through medical record review.

Changes in maternal disease activity will be assessed using the clinical relapse rate. Relapses will be identified based on medical record review and participant self-report questionnaires administered at regular intervals. Additional information, such as the timing, severity, and treatment of relapses, will be collected when available.

Infant growth data (weight, length, head circumference) will be extracted from routine clinical records from Well-Child Care Visits up to 12 months. Developmental milestones will be assessed using the Ages and Stages Questionnaire, Version 3 (ASQ-3), administered at 2, 4, 6, 8, 10, and 12 months postpartum. ASQ-3 scores are age-specific and help assess infant communication, motor, problem-solving, and social-emotional development. Higher scores generally indicate better developmental progress.

Breastmilk samples will be collected following postpartum infusions of anti-B cell therapies (e.g., ocrelizumab, rituximab), natalizumab, or monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor. Samples will be collected across 6 timepoints around the first postpartum infusion (pre-infusion; 7 days, 20 days, 30 days, 60 days, and 90 days post-infusion). Samples will be analyzed to detect the presence and concentration of these therapies in breastmilk and predict the relative transfer of medication to infants through breastmilk. Information about breastfeeding behavior including whether participants are exclusively breastfeeding, mixed feeding, or using formula, will be self-reported through accompanying survey or collected through chart review.

Maternal blood samples will be collected at various time points: during the planning stage, at 8 months of pregnancy, and during the postpartum period (1, 2, 4, and 6 months postpartum), depending on the participant's ability and willingness to provide a sample. During the postpartum period, a set of blood samples will also be collected pre-infusion, and at 30 and 60 days post-infusion, either separately or in conjunction with other postpartum time points. These samples will be analyzed to determine serum drug levels for pharmacokinetic evaluation, as well as to assess other biomarkers of interest.

Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS), which evaluates the perceived impact of fatigue on cognitive, physical, and psychosocial functioning. Scores range from 0 to 84. Higher scores indicate greater fatigue impact. This will be administered at baseline, 8 months of pregnancy, and during the postpartum period at 1, 4, 8, and 12 months.

Sleep quality will be measured using the Medical Outcomes Study Sleep Scale (MOS-SS), which evaluates multiple dimensions of sleep such as sleep disturbance, snoring, and sleep adequacy. Scores are standardized, with higher scores generally indicating worse sleep quality, depending on the subscale. The survey will be administered at baseline, 8 months of pregnancy, and during the postpartum period at 1, 4, 8, and 12 months.

Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS), a self-administered questionnaire that measures the general level of daytime sleepiness. The scale includes 8 items with scores ranging from 0 to 24, where higher scores indicate greater daytime sleepiness. The survey will be administered at baseline, 8 months of pregnancy, and during the postpartum period at 1, 4, 8, and 12 months.

The Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) will be used to assess cognitive function and neuropsychological symptoms related to multiple sclerosis (MS). This self-reported questionnaire includes multiple domains such as memory, attention, and executive function, to evaluate the cognitive impact of MS during pregnancy and postpartum. Higher scores indicate more cognitive difficulty. This will be administered at baseline, 8 months of pregnancy, and during the postpartum period at 1, 4, 8, and 12 months.

The Medical Outcomes Study Social Support Survey (19-Item Version) will assess the level of social support participants feel they have during pregnancy and postpartum. The survey includes items related to emotional, informational, and tangible support. Responses are scored on a 5-point Likert scale, with higher scores indicating greater perceived social support. This will be collected at baseline, 8 months of pregnancy, and during the postpartum period at 1, 4, 8, and 12 months.

Maternal mood and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item scale with subscales for anxiety and depression, each scored from 0 to 21. Higher scores indicate greater symptom severity. The questionnaire will be administered at baseline (pre-pregnancy or early pregnancy), 36 weeks/8 months gestation, and at 1, 4, 8, and 12 months postpartum.

Maternal mood and depression symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item scale scored from 0 to 30. Higher scores indicate more severe postpartum depression symptoms. The questionnaire will be administered at baseline (pre-pregnancy or early pregnancy), 36 weeks/8 months gestation, and at 1, 4, 8, and 12 months postpartum.

Maternal mood and depression symptoms will be assessed using Mini International Neuropsychiatric Interview (MINI), a structured diagnostic tool for mental health disorders. The interview includes specific questions and sections designed to assess the presence and severity of depressive symptoms. The questionnaire will be administered through a phone call for a short duration of around 15 minutes at 12 months postpartum.

Maternal mood and depression symptoms will be assessed using the Structured Clinical Interview for DSM-5 (SCID), a semi-structured interview to make diagnoses according to the DSM-5 criteria. The questionnaire will be administered at 12 months postpartum by the study clinician.

Maternal emotional bonding with the infant will be assessed using the Mother-to-Infant Bonding Scale (MIBS), a self-administered questionnaire designed to screen for potential bonding disorders in the postpartum period. The MIBS consists of 8 items rated on a 4-point Likert scale, with higher scores indicating greater difficulties in mother-infant bonding. The questionnaire will be administered during the postpartum period at 1, 4, 8, and 12 months.

Infant feeding practices will be assessed using a self-administered Breastfeeding Questionnaire, which captures detailed information on breastfeeding initiation, duration, frequency, exclusivity, and supplementation with formula or solid foods. The questionnaire also includes items addressing maternal perceptions, challenges, and reasons for changes in feeding practices. The questionnaire will be administered during the postpartum period at 1, 4, 8, and 12 months.

Stool samples from mothers will be collected at key time points before and after the first maternal monoclonal antibody treatment resumption (pre-infusion; 30 days and 60 days post-infusion) to evaluate changes in gastrointestinal microbial populations.

Stool samples from infant will be collected at key time points before and after the first maternal monoclonal antibody treatment resumption (pre-infusion; 30 days and 60 days post-infusion) to evaluate changes in gastrointestinal microbial populations.

Immune function of infants whose mothers received anti-B cell therapies, natalizumab, or monoclonal antibodies to calcitonin gene-related peptide (CGRP) or its receptor will be monitored using clinical data (e.g., lymphocyte counts from cord blood and infant bloodwork) when available through standard medical care.

Vaginal swab samples from mothers will be collected at a key time point to determine the effect of mAb treatment on vaginal microbial populations in mothers.