Epilepsy
Conditions
Interventions
Standard Supplementation Group:Folic acid supplementation of 0.4mg/day
High-Dose Supplementation Group:Folic acid supplementation of 2mg/day
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Female patients diagnosed with epilepsy according to the International League Against Epilepsy (ILAE) diagnostic criteria. 2.Aged 18 to 45 years. 3.Positive pregnancy test with gestational age < 8 weeks. 4.Signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Seizure occurrence within the 3 months prior to conception; 2.History of neural tube defects or other congenital malformations in previous pregnancies; 3.Presence of neural tube defects, other congenital malformations, or relevant family history in the patient; 4.Presence of neural tube defects, other congenital malformations, or relevant family history in the patient’s partner; 5.Coexisting megaloblastic anemia; 6.Coexisting malignancy or severe systemic disease (e.g., Crohn’s disease, rheumatoid arthritis, ulcerative colitis); 7.Current use of medications interfering with folate metabolism (e.g., methotrexate, sulfasalazine, antimalarials), excluding antiseizure medications; 8.Hyperhomocysteinemia(serum homocysteine concentration >15 µmol/L); 9.Long-term exposure to ionizing radiation; 10.Alcohol abuse (>500 mL/week within the past 12 months); 11.Allergy to folic acid or contraindication to its use; 12.Participation in another clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite adverse offspring outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Small Gestational Age;Incidence of Preterm Birth;Incidence of antiseizure medication (ASM) adjustments during pregnancy;Incidence of adverse events;Incidence of neurological abnormalities;Incidence of Major Congenital Malformation;Incidence of Stillbirth;Incidence of Spontaneous Abortion;Incidence of Pregnancy Complications;Incidence of seizures during pregnancy; | — |
Countries
China
Contacts
Public ContactChen Lei
West China Hospital of Sichuan University
Outcome results
None listed