Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the best treatment for pregnant women who have a condition called immune thrombocytopenia (ITP), which is when the body has low platelet levels that can lead to bleeding issues. The study is comparing two approaches: one group will receive prednisone alone, while the other group will get prednisone along with a treatment called IVIg (intravenous immunoglobulin). The goal is to see which combination is more effective and safe for managing ITP during pregnancy.

To participate in this trial, women aged 18 to 50 who are at least 12 weeks pregnant and have low platelet counts may qualify. It's important that they haven't received specific treatments for ITP during their pregnancy. Participants will be closely monitored throughout the study, and they will need to give their consent to join. If you or someone you know is considering this trial, it’s a great opportunity to contribute to research that could help improve care for future pregnant women with this condition.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-50 years old;
• • 2. Meet the diagnostic criteria for immune thrombocytopenia;
• • 3. Pregnant women with ITP without ITP-specific treatments during pregnancy;
• • 4. Gestational weeks ≥12 weeks;
• • 5. Platelet count \<30×10\^9/L, accompanied with or without bleeding symptoms.
• • 6. Willing and able to sign written informed consent.
• Exclusion Criteria:
• • 1. 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.
• • 2. Thrombocytopenia caused by pregnancy-specific conditions, such as gestational thrombocytopenia, preeclampsia, the HELLP syndrome and acute fatty liver of pregnancy.
• • 3. Secondary thrombocytopenia such as drug-related thrombocytopenia, vaccine-related thrombocytopenia, lymphoproliferative disorders, severe infection, hepatic cirrhosis and so on.
• • 4. 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;
• • 5. Current HIV infection or hepatitis B virus or hepatitis C virus infections;
• • 6. With severe heart, kidney, liver or respiratory dysfunction;
• • 7. With the medical history of mental illness;
• • 8. Have allergic reaction to prednisone or IVIg;