Neuromyelitis Optica Spectrum Disorder (NMOSD)
Conditions
Interventions
Observational group:None
Sponsors
The Third Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Females aged 18–45 years inclusive. 2.Diagnosis of AQP4-IgG-positive NMOSD according to the 2015 Wingerchuk International Consensus Diagnostic Criteria. 3.Has a confirmed intention to become pregnant within the subsequent 12 months. 4.EDSS score <= 3.0 at enrollment, with mild disability, independent ambulation, and full capacity for study follow-up. 5.No NMOSD relapse within 12 months before enrollment, with disease in stable condition. 6.On long-term maintenance immunosuppressive therapy with azathioprine at enrollment. 7.Able to comprehend the study protocol, provide voluntary written informed consent, and comply with the long-term follow-up schedule from pre-pregnancy through 1 year postpartum.
Exclusion criteria
Exclusion criteria: 1.Complicated with systemic autoimmune diseases (such as systemic lupus erythematosus, Sjögren's syndrome, etc.); 2.Complicated with severe dysfunction of major organs such as heart, liver and kidney. 3.Presence of severe psychiatric illness or cognitive dysfunction, resulting in inability to cooperate with follow-up. 4.Documented history of absolute contraindications to pregnancy, such as severe preeclampsia or recurrent miscarriage caused by uterine malformation. 5.Currently participating in any other interventional clinical trial. 6.Voluntary withdrawal and revocation of informed consent during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse or no relapse during peri-pregnancy in NMOSD patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcomes: Gestational hypertension, preeclampsia/eclampsia, gestational diabetes, thyroid dysfunction during pregnancy, mode of delivery (natural delivery/cesarean section), major obstetric complications (such as postpartum hemorrhage, puerperium infection, etc.);Fetal/neonatal outcomes: miscarriage (=20 weeks of gestation), gestational age at birth, preterm birth (<37 weeks of gestation), birth weight, Apgar score, congenital malformations, admission status and duration to the neonatal intensive care unit (NICU).; | — |
Countries
China
Contacts
Public ContactXiao Li
The Third Affiliated Hospital Sun Yat-sen University
Outcome results
None listed