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A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT00194987
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 28, 2018
Sponsor:
Collaborators:
New York Presbyterian Hospital
Columbia University
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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 fetus (which may result in serious fetal injuries).

Condition or disease Intervention/treatment Phase
Alloimmune Thrombocytopenia Fetal Alloimmune Thrombocytopenia Drug: IVIG (Intravenous Immunoglobulin) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
Study Start Date : April 2001
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : June 30, 2015

Arm Intervention/treatment
Experimental: 3 Drug: IVIG (Intravenous Immunoglobulin)
one to two gram per kg once-twice weekly




Primary Outcome Measures :
  1. To raise the platelet count of affected fetus. [ Time Frame: 20-30 weeks ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194987


Locations
United States, New York
New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
New York Presbyterian Hospital
Columbia University
Investigators
Principal Investigator: James B Bussel, M.D. Weill Medical College of Cornell University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00194987     History of Changes
Other Study ID Numbers: 0102004801
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

Keywords provided by Weill Medical College of Cornell University:
Alloimmune thrombocytopenia
Fetal alloimmune thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs