Pregnancy Registry, Infants, Serum/Milk Analysis (PRISMA): Pregnancy Registry for Women With Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Maternal Disease Activity During Pregnancy and Postpartum Assessed by Expanded Disability Status Scale (EDSS)
研究概览
简要总结
PRISMA, is a pregnancy registry study, focused on comprehensively collecting information about pregnancy in women with chronic neurological conditions from across the United States and internationally.
Depending on their specific condition (MS, CIS, NMOSD, or other) and their specific treatment, participants will be asked to contribute to different aspects of the study. (1) The biosamples will be blood, breast milk, infant stool, maternal stool and vaginal swab samples, collected at specific time points. (2) The online surveys will be collected at specific time points. All study activities will be discussed with participants upon enrollment.
By collecting this information, the investigators hope to gain deeper insights into the relationship between pregnancy, the neurological condition, and maternal and infant health. For example, one of the sub-studies focuses on breast milk collection for women planning postpartum treatment with Ocrevus, Rituxan, Briumvi or Kesimpta.
This study is fully remote and all sample collection is optional, so participants can choose which types of samples they wish to provide. For blood draws, participants can schedule a home visit through ExamOne, making participation even more convenient.
The investigators aim to enroll women with chronic neurological conditions who are planning pregnancy, currently pregnant, or within one year postpartum.
详细描述
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:
- 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.]
- 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.
- Biospecimen Collection, Storage & Later Batch Analysis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant or contemplating pregnancy
- •Female, aged 18 to 64 years
- •Diagnosis of one of the following conditions:
- •Clinically Isolated Syndrome (CIS) or Multiple Sclerosis (MS), based on the 2010 McDonald Criteria
- •Neuromyelitis Optica Spectrum Disorder (NMOSD)
- •Inflammatory Bowel Disease (IBD)
- •Rheumatoid Arthritis (RA)
- •Myasthenia Gravis
- •Other chronic neurological conditions
- •Willing to provide biosamples and/or complete surveys at specified timepoints
- •Women without a chronic condition who are pregnant or contemplating pregnancy (as part of the control group)
排除标准
- •- Unwillingness to provide informed consent
研究组 & 干预措施
Healthy Controls
Healthy adult women who are planning pregnancy, currently pregnant, or postpartum.
Multiple sclerosis (MS)
Adult women diagnosed with multiple sclerosis (MS) who are planning pregnancy, currently pregnant, or postpartum.
Clinically isolated syndrome (CIS)
Adult women diagnosed with clinically isolated syndrome (CIS) who are planning pregnancy, currently pregnant, or postpartum.
Neuromyelitis optica spectrum disorder (NMOSD)
Adult women diagnosed with neuromyelitis optica spectrum disorder (NMOSD) who are planning pregnancy, currently pregnant, or postpartum.
Myasthenia gravis
Adult women diagnosed with myasthenia gravis who are planning pregnancy, currently pregnant, or postpartum.
结局指标
主要结局
Maternal Disease Activity During Pregnancy and Postpartum Assessed by Expanded Disability Status Scale (EDSS)
时间窗: From pre-pregnancy (if applicable) through 12 months postpartum
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.
Maternal Disease Activity During Pregnancy and Postpartum Assessed by MRI Findings
时间窗: From pre-pregnancy (if applicable) through 12 months postpartum
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.
Maternal Disease Treatment Course During Pregnancy and Postpartum Assessed by Disease Modifying Therapy (DMT) Use
时间窗: From pre-pregnancy (if applicable) through 12 months postpartum
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.
Maternal Disease Activity During Pregnancy and Postpartum Assessed by Clinical Relapse Rates
时间窗: From pre-pregnancy (if applicable) through 12 months postpartum
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.
次要结局
- Infant Growth and Development Outcomes Assessed by Chart Review and ASQ-3(From birth through 12 months postpartum)
- Detection and Concentration of Monoclonal Antibodies in Breastmilk(From first infusion postpartum through 12 months postpartum)
- Concentration of Monoclonal Antibodies and Disease-Related Biomarkers in Maternal Blood(From the planning pregnancy (if applicable) to 6 months postpartum)
- Maternal Fatigue During Pregnancy and Postpartum Assessed by Modified Fatigue Impact Scale (MFIS)(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)(From pre-pregnancy (if applicable) through 12 months postpartum)
- Maternal Sleep Quality During Pregnancy and Postpartum Assessed by Epworth-Sleepiness Scale (ESS)(From pre-pregnancy (if applicable) through 12 months postpartum)
- Maternal Cognitive Function During Pregnancy and Postpartum Assessed by Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)(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)(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)(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)(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)(12 months postpartum)
- Maternal Per-partum Depression Status During Pregnancy and Postpartum Assessed by Structured Clinical Interview for DSM-5 (SCID)(12 months postpartum)
- Maternal Bonding with Infant Assessed by Mother-to-Infant Bonding Scale (MIBS)(From 1 month through 12 months postpartum)
- Infant Feeding Practices Assessed by Breastfeeding Questionnaire(From 1 month through 12 months postpartum)