drugset / Trial / NCT00194987
A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
Phase 2/3
Completed
102 enrolled
Weill Medical College of Cornell University
Columbia University · collabNew York Presbyterian Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purposes of this study are to provide medical management by giving treatment to the mother that will bring up the fetal platelet count and to minimize the number of invasive procedures to the fetus (which may result in serious fetal injuries).
Timeline
- Start
- 2001-04
- Primary completion
- 2015-06-30
- Completion
- 2015-06-30
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Intravenous Immunoglobulin | Protein / enzyme biologic | 1 g/kg | Intravenous |
| Subject | Intravenous Immunoglobulin | Protein / enzyme biologic | 2 g/kg | Intravenous |
| Subject | Prednisone | Other / unclassified | 0.5 mg/kg | Oral |