A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

• Status: Completed
• Trial end date: 2015-06-30
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborators: Columbia University; New York Presbyterian Hospital
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Prednisone; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

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 Criteria:

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