Status:
COMPLETED
A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
New York Presbyterian Hospital
Columbia University
Conditions:
Alloimmune Thrombocytopenia
Fetal Alloimmune Thrombocytopenia
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
PHASE3
Brief 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 fetu...
Eligibility Criteria
Inclusion
- Pregnant women are eligible for inclusion into the Very High Risk Group if they:
- 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
- Women are not eligible for inclusion into the Very High Risk Group if they:
- 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
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2015
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00194987
Start Date
April 1 2001
End Date
June 30 2015
Last Update
November 7 2018
Active Locations (1)
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1
New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, United States, 10021