None listed
Conditions
Brief summary
The study aims to understand how pregnancy affects women with Multiple Sclerosis (MS) or Neuromyelitis Optica Spectrum Disorder (NMOSD). In the past, pregnancy was thought to worsen MS, but a 1990s study contradicted this, revealing reduced relapses during pregnancy followed by increased postpartum relapses, especially in severe cases. Recent research, including CI Jokubaitis’ work, suggests that pregnancy might delay MS onset and diminish long-term disability, as symptoms often diminish or entirely disappear during pregnancy. This study delves into the biological changes during pregnancy in women with MS and NMOSD. A central hypothesis is that epigenetic factors, like altered DNA methylation, underlie enhanced disability outcomes in MS. Additionally, the study explores the role of natural killer (NK) cells in mediating these improvements. The study has several key goals: revealing cellular and molecular changes, which involves comparing immune cells and genomic and proteomic markers in pregnant women with MS and a non-MS population; identifying relapse biomarkers by investigating whether ratios of immune cells and hormone levels (estrogen, progesterone) correlate with clinical and MRI outcomes during pregnancy and postpartum. Understanding improved disability outcomes by analysing molecular shifts during pregnancy in women with MS and NMOSD with improved disability outcomes versus those without. The study enrols participants into four groups: non-MS controls, healthy pregnant women, nulligravida MS (or NMOSD) patients, and pregnant MS (or NMOSD) patients. By comparing these groups, researchers aim to unravel the complex connections between pregnancy, immune changes, and the progression of MS/NMOSD. MS and NMOSD women will be analysed separately. This study holds the promise of shedding light on the potential benefits of pregnancy for women with MS/NMOSD and providing fresh insights into new therapeutic approaches.
Interventions
The study aims to characterise the hormonal, cellular and epigenetic profiles of healthy women and women with MS or NMOSD before, during and after pregnancy. Our study seeks to elucidate the molecular mechanisms behind the potential long-term benefit of pregnancy in women with MS and the potential drawbacks in the context of NMOSD. This exploration may contribute to a deeper understanding of the pathogenesis and pathophysiology of MS or NMOSD, and offer novel therapeutic targets within the epige
The study aims to characterise the hormonal, cellular and epigenetic profiles of healthy women and women with MS or NMOSD before, during and after pregnancy. Our study seeks to elucidate the molecular mechanisms behind the potential long-term benefit of pregnancy in women with MS and the potential drawbacks in the context of NMOSD. This exploration may contribute to a deeper understanding of the pathogenesis and pathophysiology of MS or NMOSD, and offer novel therapeutic targets within the epigenome. During the screening process, participants will be requested to sign the Patient Informed Consent Form and complete questionnaires concerning significant environmental and clinical factors that could impact the epigenome. Subsequently, they will be asked to provide blood samples at various timepoints and to recomplete the questionnaire. These assessments are scheduled for the 1st trimester (10-14 weeks) of pregnancy, the 3rd trimester (32-38 weeks), 3months after giving birth, 1 year, and 3 years. Study nurses will collect blood samples, which will then be transferred to Monash facilities for processing. Plasma, serum, immune cell subpopulations, DNA and RNA will be extracted from whole blood samples. For women affected by MS or NMOSD, we will request access to routine MRIs that are conducted as a part of regular care at different timepoints. This will allow us to investigate the impact of pregnancy on MRI outcomes. Participants are enrolled prospectively into four distinct study arms. Arms A and B comprise non-MS controls: a cohort of non-MS nulligravida women (Arm A) and non-MS primigravida women (Arm B). MS-affected primigravida women constitute Arm C, while MS-affected nulligravida women form Arm D.
Sponsors
Monash University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
- females - women with clinically definite MS or NMOSD - nulligravida healthy women - primigravida healthy women - eligible for Medicare
Exclusion criteria
- unable or unwilling to give informed consent - has another neuroimmunological condition - is not nulligravida/primigravida
Outcome results
None listed