A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
NCT00194987 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2018-11-07
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).
Conditions
- Alloimmune Thrombocytopenia
- Fetal Alloimmune Thrombocytopenia
Interventions
- DRUG
-
IVIG (Intravenous Immunoglobulin)
one gram per kg of IVIG per infusion given either once or twice
- DRUG
-
in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day
Sponsors & Collaborators
-
New York Presbyterian Hospital
collaborator OTHER - collaborator OTHER
-
Weill Medical College of Cornell University
lead OTHER
Principal Investigators
-
James B Bussel, M.D. · Weill Medical College of Cornell University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-04-30
- Primary Completion
- 2015-06-30
- Completion
- 2015-06-30
Countries
- United States
Study Locations
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