ClinicalTrials.gov record NCT07653984

Cohort Study on Neuroimmune Diseases in the Reproductive Age

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Cohort Study on Neuroimmune Diseases in the Reproductive Age

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age20 years old to 55 years old
SexFemale
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational cohort study of women of reproductive age (20–55) with several neuroimmune diseases and age-matched healthy women planning pregnancy. The study follows participants from pre-pregnancy through each trimester and up to 12 months postpartum (assessment period spans up to 25 months), collecting clinical exams, imaging, blood biomarkers, questionnaires, and delivery/neonatal data. The study aims to build detailed clinical and biological data about disease activity, pregnancy and newborn outcomes, and drug concentrations when applicable.

What it is studying. The study is testing how pregnancy and the peripartum period relate to disease activity and outcomes across several neuroimmune disorders. It measures relapse rates before pregnancy, during pregnancy, and postpartum; collects clinical disability and symptom scores; obtains repeated imaging (brain, spinal cord, optic nerve) and visual tests; and measures many blood biomarkers (including autoantibodies, cytokines, neurofilament light chain, and lymphocyte subsets). Cerebrospinal fluid markers are collected only if lumbar puncture is done for clinical reasons. For participants treated with satralizumab, maternal, cord blood, and breast milk drug concentrations are measured, and neonatal growth and clinical outcomes are recorded.

What the researchers hope to learn. To generate detailed clinical, imaging, biomarker, and pharmacokinetic data on pregnancy-associated neuroimmune diseases; to document relapse patterns across pre-pregnancy, pregnancy, and postpartum periods; to compare maternal and neonatal outcomes with healthy controls; and to provide evidence to inform disease-management questions in the reproductive age.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Patient Group: A total of fifty participants are expected to be enrolled.
  • Women aged 20-55 years with childbearing potential.
  • Voluntary informed consent.
  • Availability of complete personal information.
  • 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.
  • Age- and sex-matched women of childbearing age with plans for pregnancy
  • Voluntary informed consent.
  • Availability of complete personal information.

Exclusion criteria

  • Patient Group:
  • Patients with an undetermined or unconfirmed diagnosis.
  • Incomplete personal information that cannot be obtained through follow-up.
  • Participants who voluntarily withdrew from the study and revoked informed consent.
  • Healthy Control Group:
  • Individuals diagnosed with neuroimmune-related disorders.
  • Incomplete personal information that cannot be obtained through follow-up.
  • Participants who voluntarily withdrew from the study and revoked informed consent.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are followed from before pregnancy through pregnancy and up to 1 year after delivery (assessment schedule extends up to about 25 months). Study visits include clinical exams, questionnaires about symptoms and quality of life, blood sampling and other laboratory tests, MRI scans, visual testing, fetal ultrasounds, and collection of delivery and neonatal data. Lumbar puncture (spinal tap) is performed only in a subset of patients when clinically indicated. For patients receiving satralizumab, maternal serum, cord blood, breast‑milk, and neonatal blood samples (postnatal days 5 and 26) may be collected.

How the study is structured. A prospective observational cohort with two groups: women with the listed neuroimmune diseases who plan pregnancy, and age-matched healthy women planning pregnancy. Participants have a baseline (pre-pregnancy) assessment, trimester visits during pregnancy, and postpartum visits (including 3, 6, and 12 months), with repeated exams, questionnaires, blood tests, MRI scans, and delivery/newborn data. No treatments are assigned by the study; some procedures (lumbar puncture, satralizumab measurements) occur only when clinically indicated or applicable.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Apr 21, 2024
Primary completion
January 2030 (estimated)
Study completion
April 2030 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Jun 17, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Principal investigator
Wei Qiu, Chief Physician
Third Affiliated Hospital, Sun Yat-Sen University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
relapse
A condition that improved with treatment and has since returned or worsened.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Control Group
The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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