A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
NCT ID: NCT00194987
Last Updated: 2018-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
102 participants
INTERVENTIONAL
2001-04-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IVIG x 2
IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT
IVIG (Intravenous Immunoglobulin)
one gram per kg of IVIG per infusion given either once or twice
IVIG x 1 + prednisone
IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT
IVIG (Intravenous Immunoglobulin)
one gram per kg of IVIG per infusion given either once or twice
prednisone
in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day
Interventions
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IVIG (Intravenous Immunoglobulin)
one gram per kg of IVIG per infusion given either once or twice
prednisone
in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day
Eligibility Criteria
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Inclusion Criteria
* are PLA-1 (platelet antigen A1) negative and have known platelet incompatibility with their fetus
* have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation (as best as could be estimated)
* are less than 19 weeks gestation
Pregnant women are eligible for inclusion into the High Risk Group if they:
* are PLA-1 negative and have known platelet incompatibility with the fetus
* have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation (as best as could be estimated)
* are between 12-30 weeks gestation
Pregnant women are eligible for inclusion into the Standard Risk Group if they:
* are PLA-1 negative and have known platelet incompatibility with the fetus
* have not had a previous child who suffered an antenatal hemorrhage
* are between 20-30 weeks gestation
Exclusion Criteria
* have had a previous child who suffered an antenatal hemorrhage after 28 weeks gestation
* are greater than 19 weeks gestation
Women are not eligible for inclusion into the High Risk Group if they:
* have had a previous child who suffered an antenatal hemorrhage prior to 28 weeks gestation
* are greater than 30 weeks gestation
Women are not eligible for inclusion into the Standard Risk Group if they:
* have had a previous child who suffered an antenatal hemorrhage
* are greater than 30 weeks gestation
18 Years
50 Years
FEMALE
No
Sponsors
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New York Presbyterian Hospital
OTHER
Columbia University
OTHER
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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James B Bussel, M.D.
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, United States
Countries
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References
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Lakkaraja M, Jin JC, Manotas KC, Vinograd CA, Ferd P, Gabor J, Wissert M, Berkowitz RL, McFarland JG, Bussel JB. Blood group A mothers are more likely to develop anemia during antenatal intravenous immunoglobulin treatment of fetal and neonatal alloimmune thrombocytopenia. Transfusion. 2016 Oct;56(10):2449-2454. doi: 10.1111/trf.13779. Epub 2016 Sep 9.
Berkowitz RL, Lesser ML, McFarland JG, Wissert M, Primiani A, Hung C, Bussel JB. Antepartum treatment without early cordocentesis for standard-risk alloimmune thrombocytopenia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):249-55. doi: 10.1097/01.AOG.0000270302.80336.dd.
Other Identifiers
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0102004801
Identifier Type: -
Identifier Source: org_study_id
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