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

The aim of this project is to develop a repository of samples for women who are pregnant and have chronic conditions, including demyelinating diseases -- either multiple sclerosis (MS), clinically isolated syndrome (CIS) or NMOSD (neuromyelitis optica spectrum disorders), chronic inflammation --- inflammatory bowel disease (IBD), rheumatoid arthritis (RA), lupus, myasthenia gravis (MG), primary headache disorders, or other chronic neurological conditions. Please note that the investigators refer to "MS" in the rest of the application.

This repository will include:

1. Maternal Outcomes (disease-related outcomes, depression, social support, breastfeeding and pregnancy-related outcomes):

* Obtained via interviews, surveys, and medical record review during pregnancy planning, pregnancy (Baseline and 36w gestation) and postpartum (1, 4, 8, 12M) * Maternal radiographic information will be collected from data available in the medical records. \[Radiographic information will be information captured from the medical record, not obtained during the study visits. No radiology exams will be conducted as part of this research study. If deemed necessary for the subject's routine clinical care, the investigators will record the results of an MRI within 12M postpartum.\] 2. Infant Outcomes (growth, development, immunization, infection, breastfeeding, etc.)

* Obtained via medical record review (up to 12M) * Monitored via maternal completion of the Ages and Stages Questionnaires-Version 3 (ASQ3) to track infant development outcomes (communication, gross motor, fine motor, problem solving, and person-social) at 2, 4, 6, 8, 10, and 12M of age. 3. Biospecimen Collection, Storage \& Later Batch Analysis:

* Maternal blood samples will be collected for up to the following time points: Baseline (including if planning pregnancy), 3M gestation, 6M gestation, 8M gestation, 1M postpartum, 3M postpartum, and 6M postpartum. Samples will be processed and stored as serum, plasma and peripheral blood mononuclear cells (PBMCs). * Serial breastmilk samples will be collected, for both before and after treatment if applicable, and up to 2-3 years postpartum. These samples will be used to determine the concentrations of medications in breastmilk relative to maternal serum. * Serial maternal and infant gut microbiome samples will be collected before and after treatment (anytime during the lactation period which can extend up to 2-3 years postpartum) to determine the effect of mAb treatment on gut microbial populations in mothers and infants. Mothers will be asked to complete food frequency questionnaires for themselves and their infants at the time of each sample collection. * Maternal vaginal swab sample will be collected in their 36 weeks of gestation (OR 8M pregnancy) to determine the effect of mAb treatment on vaginal microbial populations in mothers. Mothers will be asked to complete questionnaires regarding their diet and medication for themselves at the time of each sample collection. * Serial maternal blood samples will be collected (including before and post treatment) anytime up to 2-3 years postpartum. These samples will be used to determine concentrations of medications in breastmilk relative to serum and to determine the effect of maternal treatment on mother and infant gut microbiome.

* Timing of sample collection for participants treated with mAb will depend on the treatment type, dosing and infusion schedule.

Participants who are healthy controls or who are not receiving specific medications of interest will provide

* A single breastmilk sample at 2M, 3M, and 4M * A maternal and infant gut microbiome sample at 2M, 3M, and 4M postpartum * Maternal vaginal swab sample at 36 weeks of gestation (OR 8M pregnancy). * Maternal blood samples will be collected at corresponding timepoints 2M, 3M and 4M postpartum (to be processed and stored as serum, plasma, and PBMCs)

• Infant Growth and Development Outcomes Assessed by Chart Review and ASQ-3 [Time frame: From birth through 12 months postpartum]
• Detection and Concentration of Monoclonal Antibodies in Breastmilk [Time frame: From first infusion postpartum through 12 months postpartum]
• Concentration of Monoclonal Antibodies and Disease-Related Biomarkers in Maternal Blood [Time frame: From the planning pregnancy (if applicable) to 6 months postpartum]
• Maternal Fatigue During Pregnancy and Postpartum Assessed by Modified Fatigue Impact Scale (MFIS) [Time frame: From pre-pregnancy (if applicable) through 12 months postpartum]
• Maternal Sleep Quality During Pregnancy and Postpartum Assessed by Medical Outcomes Study Sleep Scale (MOS-SS) [Time frame: From pre-pregnancy (if applicable) through 12 months postpartum]
• Maternal Sleep Quality During Pregnancy and Postpartum Assessed by Epworth-Sleepiness Scale (ESS) [Time frame: From pre-pregnancy (if applicable) through 12 months postpartum]
• Maternal Cognitive Function During Pregnancy and Postpartum Assessed by Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) [Time frame: From pre-pregnancy (if applicable) through 12 months postpartum]
• Social Support During Pregnancy and Postpartum Assessed by Medical Outcomes Study Social Support Survey (19-Item Version) [Time frame: From pre-pregnancy (if applicable) through 12 months postpartum]
• Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Hospital Anxiety and Depression Scale (HADS) [Time frame: From pre-pregnancy (if applicable) through 12 months postpartum]
• Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Edinburgh Postnatal Depression Scale (EPDS) [Time frame: From pre-pregnancy (if applicable) through 12 months postpartum]
• Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Mini International Neuropsychiatric Interview (MINI) [Time frame: 12 months postpartum]
• Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Structured Clinical Interview for DSM-5 (SCID) [Time frame: 12 months postpartum]