Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy
Prednisone Plus IVIg Compared With Prednisone for Immune Thrombocytopenia During Pregnancy
Peking University People's Hospital
100 participants
Oct 19, 2023
INTERVENTIONAL
Conditions
Summary
This is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus IVIg to prednisone monotherapy in the treatment of immune thrombocytopenia (ITP) in pregnancy.
Eligibility
Inclusion Criteria6
- Age 18-50 years old;
- Meet the diagnostic criteria for immune thrombocytopenia;
- Pregnant women with ITP without ITP-specific treatments during pregnancy;
- Gestational weeks ≥12 weeks;
- Platelet count <30×10\^9/L, accompanied with or without bleeding symptoms.
- Willing and able to sign written informed consent.
Exclusion Criteria8
- Have a known diagnosis of other autoimmune diseases, confirmed medical history or laboratory findings within positive anti-nuclear antibodies (>1:80), anti-cardiolipin antibodies, lupus anticoagulant factors or direct Coombs' test.
- Thrombocytopenia caused by pregnancy-specific conditions, such as gestational thrombocytopenia, preeclampsia, the HELLP syndrome and acute fatty liver of pregnancy.
- Secondary thrombocytopenia such as drug-related thrombocytopenia, vaccine-related thrombocytopenia, lymphoproliferative disorders, severe infection, hepatic cirrhosis and so on.
- With other underlying diseases that may cause thrombocytopenia, such as: malignant disease, megaloblastic anemia, aplastic anemia, myelodysplasia syndrome, myeloid fibrosis, disseminated intravascular coagulation, thrombotic thrombocytopenic purpura, Hemolytic uremic syndrome, disseminated intravascular coagulation and so on;
- Current HIV infection or hepatitis B virus or hepatitis C virus infections;
- With severe heart, kidney, liver or respiratory dysfunction;
- With the medical history of mental illness;
- Have allergic reaction to prednisone or IVIg;
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Interventions
Prednisone po, 20mg per day for 4 weeks, if response (Plt 30-100×100\^g/L), gradually taper to the maintenance dose of 5-10mg per day until 6 weeks after delivery; if not response, gradually taper to withdrawal.
IVIg 400mg/kg (≤20g for the total dose) per day for 5 days, and repeated in the case of lack of response by day 14
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06577909