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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Linyi People's Hospital | OTHER |
| The Affiliated Hospital of Qingdao University |
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The purpose of this study was to observe the clinical efficacy and adverse reactions of rhTPO in the treatment of pregnancy-induced thrombocytopenia.
The project is undertaken by Qilu Hospital of Shandong University and other 6 well-known hospitals in China. The investigators anticipate to undertaking a concurrent control, multicentre trial including 60 pregnancy associated ITP adult patients which are ineffective for first-line treatment or platelets infusion and 30 healthy pregnancy control. 30 of the ITP patients are selected to receive rhTPO(given different dose according to the platelet count, the risk of bleeding and delivery), the other ITP patients are selected not to receive rhTPO. Platelet count, bleeding and other symptoms of ITP patients and their newborns are evaluated after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the rhTPO for the treatment of pregnancy with ITP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Accepting the treatment of rhTPO according platelet and bleeding condition |
|
| non-administered group | Active Comparator | No rhTPO will be used. If necessary, the patients will be given transfusion of platelets according to the their conditions. |
|
| healthy control group | No Intervention | Healthy pregnant women and no use of any medicine。 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human thrombopoietin | Drug | If platelet count <30×10^9/L and with haemorrhage or risk of bleeding,the patients began to receive subcutaneous injection of TPO with the dose of 300 Unit/kg qd,duration ≤14 days;If platelet count is between 30×10^9/L and 50×10^9/L, the dose will be 300 Unit/kg qod;If platlet count ≥100×109/L, stop this treatment;After delivery, if platelet count <30×10^9/L and with haemorrhage or risk of bleeding,subcutaneous injection of TPO with the dose of 300 Unit/kg qd or qod will be given at a duration ≤14 days;If platelet count is between 30×10^9/L and 50×10^9/L, the dose will be 300 Unit/kg qw;If platlet count ≥100×109/L, stop the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet count during delivery | Platelet count during delivery will be assessed | up to 2 years per subject |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events in neonates | The number and frequency of therapy associated adverse events in neonates | up to 2 years per subject |
| platlet count of newborns | Platelet counts of D1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Hou, Dr | Contact | +86-531-82169114 | 9879 | houming@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Hou,, Dr | Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital, Shandong University | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D013926 | Thrombopoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Zhongshan Bo Ai Hospital | OTHER |
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|
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| Platelet Concentrate | Drug | according to the their conditions, use if necessary |
|
| up to 42 days per newborn |
| Adverse events in parturients | The number and frequency of therapy associated adverse events in parturients | up to 2 years per subject |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |