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.
The investigators are undertaking a prospective, parallel group, multicenter, randomized controlled trial in pregnant patients with treat-naive ITP. A total of 100 participants are randomized to two groups with the 1:1 ratio: prednisone plus IVIg group versus prednisone monotherapy group. Participants will receive prednisone 20mg per day for 4 weeks plus IVIg 400mg/Kg (total dose ≤20g per day) for 5 days or prednisone 20mg monotherapy per day for 4 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Time to response and platelet counts of newborns are investigated. Adverse events including participants and their newborns are also recorded throughout and after the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall Response
Achieving a platelet count of≥30×10\^9/L and at least a doubling of the baseline platelet count without administration of any other ITP-specific treatment, and the absence of bleeding
Time frame: 4 weeks
Complete Response
Platelet count ≥100×10\^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding
Time frame: 4 weeks
Early response
Platelet count ≥30×10\^9/L and at least doubling baseline at 1 week
Time frame: 1 week
relapse
After the treatment is effective, the platelet count drops below 30×10\^9/L or drops to less than 2 times the basal value, or bleeding symptoms occur
Time frame: 1 year
Time to Response
The day achieving OR
Time frame: 4 weeks
Time to relapse (duration of efficacy)
The time from achievement of CR or R to time of relapse
Time frame: 1 year
Platelet counts at delivery
Platelet counts at delivery
Time frame: At delivery
Platelet counts of newborns
Platelet counts of d1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs
Time frame: up to 42 days per newborn
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Adverse events in parturients
up to 2 years per subject
Time frame: 2 years