This trial is active, not recruiting.

Conditions immune thrombocytopenia, pregnancy
Treatment dexamethasone
Phase phase 2/phase 3
Sponsor Peking University People's Hospital
Start date January 2016
End date December 2017
Trial size 70 participants
Trial identifier NCT02751593, pregnancy and thrombocytopenia


The project was undertaking by Peking University People's Hospital and other well-known hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of ITP in pregnancy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
dexamethasone 40mg/d for 4 days
dexamethasone 40mg/d for 4 days

Primary Outcomes

Response rate (CR+R)
time frame: 3 months

Secondary Outcomes

Platelet count
time frame: 2 years
Adverse events
time frame: 2 years
live birth rate
time frame: 2 years

Eligibility Criteria

Female participants from 20 years up to 50 years old.

Inclusion Criteria: - Subject is between 20-50 years old. - After 12 weeks gestation. - Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia. - Patients who have no response or relapsed after Corticosteroid or IVIG. - Patients developed refractoriness to platelet transfusion. - To show a platelet count < 30×10^9/L, and with bleeding manifestations. - Willing and able to sign written informed consent. Exclusion Criteria: - Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. - Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit. - Current HIV infection or hepatitis B virus or hepatitis C virus infections. - Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. - Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia). - Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test. - Patients who are deemed unsuitable for the study by the investigator.

Additional Information

Official title Thrombocytopenia in Gestational Period
Description The investigators are undertaking a multicenter, open-labeled, pilot study of 50 ITP patients in pregnancy from Peking University People's Hospital and other well-known hospitals in China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given dexamethasone intravenously at a dose of 40mg every day for four days. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Peking University People's Hospital.