Clinical trial · Observational
Cohort Study on Neuroimmune Diseases in the Reproductive Age
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neuroimmune diseases are more prevalent among women of reproductive age. Studies have shown that neuroimmune diseases may impact fertility. Therefore, effective management of neuroimmune diseases during pregnancy is particularly important. This study included a follow-up period of up to five years in patients with pregnancy-associated neuroimmune disorders. Data collected included relapse frequency, symptomatology, imaging findings, treatment regimens, peripheral blood profiles, EDSS scores, and MRI results. In addition, maternal drug concentrations, postpartum relapse rates, and neonatal development were monitored after delivery. Following the successful completion of the five-year follow-up, the research team plans to continue the prospective epidemiological study with ten-year follow-up phases. The aim of this study is to generate detailed clinical data on pregnancy-associated autoimmune diseases and to equip clinicians with evidence-based strategies for optimizing disease management during the reproductive age.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Encephalitis | — | UNRESOLVED | — |
| Guillain-Barré Syndrome (GBS) | — | UNRESOLVED | — |
| Multiple Sclerosis | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
| Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) | — | UNRESOLVED | — |
| Neuromyelitis Optica Spectrum Disorders (NMOSD) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Patient group
- description
- Patient group: Age-matched women with neuroimmune diseases and fertility plans were recruited from the Fertility and Neuroimmune Diseases Multidisciplinary Outpatient Clinic of the Third Affiliated Hospital, Sun Yat-sen University for epidemiological investigation and clinical prospective study.
- label
- Healthy control group
- description
- Healthy control group: Age-matched healthy women planning pregnancy were recruited from the Department of Obstetrics at the Third Affiliated Hospital, Sun Yat-sen University for epidemiological and prospective clinical investigation.
Primary outcomes (64)
- measure
- Annual recurrence rate of neuroimmune diseases
- timeFrame
- The assessment period includes the period from the start of enrollment to 1 year postpartum, up to a maximum of 25 months.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Patient Group: A total of fifty participants are expected to be enrolled. 1. Women aged 20-55 years with childbearing potential. 2. Voluntary informed consent. 3. Availability of complete personal information. 4. A confirmed diagnosis of neuromyelitis optica spectrum disorder (NMOSD), multiple sclerosis (MS), autoimmune encephalitis, myasthenia gravis, Guillain-Barré syndrome, or myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). Healthy Control Group: A total of fifty healthy women are expected to be included. 1. Age- and sex-matched women of childbearing age with plans for pregnancy 2. Voluntary informed consent. 3. Availability of complete personal information. Exclusion Criteria: * Patient Group: 1. Patients with an undetermined or unconfirmed diagnosis. 2. Incomplete personal information that cannot be obtained through follow-up. 3. Participants who voluntarily withdrew from the study and revoked informed consent. Healthy Control Group: 1. Individuals diagnosed with neuroimmune-related disorders. 2. Incomplete personal information that cannot be obtained through follow-up. 3. Participants who voluntarily withdrew from the study and revoked informed consent.
References
Publications (31)
- BACKGROUNDCarra-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. PMID 36453174
- BACKGROUNDLongbrake E. Myelin Oligodendrocyte Glycoprotein-Associated Disorders. Continuum (Minneap Minn). 2022 Aug 1;28(4):1171-1193. doi: 10.1212/CON.0000000000001127. PMID 35938661
- BACKGROUNDCobo-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. PMID 30980491
- BACKGROUNDLupo J, Germi R, Jean D, Baccard-Longere M, Casez O, Besson G, Rouge A, Boutonnat J, Schwebel C, Hoffmann P, Morand P. Guillain-Barre syndrome and cytomegalovirus infection during pregnancy. J Clin Virol. 2016 Jun;79:74-76. doi: 10.1016/j.jcv.2016.04.010. Epub 2016 Apr 14. PMID 27105316
- BACKGROUNDPacheco 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. PMID 27741183
- BACKGROUNDWillison 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. PMID 26948435
- BACKGROUNDMagley 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.