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A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Information source: Weill Medical College of Cornell University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alloimmune Thrombocytopenia; Fetal Alloimmune Thrombocytopenia

Intervention: IVIG (Intravenous Immunoglobulin) (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Weill Medical College of Cornell University

Official(s) and/or principal investigator(s):
James B Bussel, M.D., Principal Investigator, Affiliation: Weill Cornell Medical College

Overall contact:
Megan Wissert, R.N.C., Phone: 212-746-3416, Email: mwissert@nyp.org

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).

Clinical Details

Official title: A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment

Primary outcome: To raise the platelet count of affected fetus.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

Pregnant women are eligible for inclusion into the Very High Risk Group if they:

- are PLA-1 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

Locations and Contacts

Megan Wissert, R.N.C., Phone: 212-746-3416, Email: mwissert@nyp.org

New York Presbyterian Hospital-Weill Cornell Medical Center, New York, New York 10021, United States; Recruiting
Megan Wissert, R.N.C., Phone: 212-746-3416, Email: mwissert@nyp.org
James B Bussel, M.D., Principal Investigator
Additional Information

Starting date: April 2001
Last updated: May 20, 2008

Page last updated: November 03, 2008

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