Randomized, open-label study to compare the efficacy and safety of prednisone plus recombinant human thrombopoietin (rhTPO) compared to prednisone monotherapy for the treatment of immune thrombocytopenia in pregnancy
The investigators are undertaking a parallel group, randomized controlled trial of adults with ITP in pregnancy in China. Patients were randomized to prednisone plus rhTPO and prednisone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Prednisone po, 20mg per day for 2 weeks, if response (Plt 30-100×100\^g/L),gradually taper to the maintenance dose(5-10mg per day)until 6 weeks after delivery; if not response, gradually taper to withdrawal.
rhTPO im, 300U/kg per day for 2 weeks, if response (Plt 30-100×100\^g/L), taper to 300U/kg for twice per week until 6 weeks after delivery; if not response, drug withdrawal.
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, China
RECRUITINGResponse
Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.
Time frame: day 14
Platelet counts at delivery
Platelet counts at delivery
Time frame: At delivery
Number of patients with bleeding
Number of patients with bleeding symptome
Time frame: During treatment(up to 6 weeks after delivery)
Number of patients with adverse events
Number of patients with adverse events
Time frame: During treatment(up to 6 weeks after delivery)
Platelet counts of newborns
Platelet counts of newborns
Time frame: at delivery
Number of newborns with adverse events
Number of newborns with adverse events
Time frame: During treatment(up to 6 weeks after delivery)
Loss of response
Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)
Time frame: During treatment(up to 6 weeks after delivery)
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