A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
This study is currently recruiting participants.
(see Contacts and Locations)
Verified June 2013 by Weill Medical College of Cornell University
Sponsor:
Weill Medical College of Cornell University
Collaborators:
New York Presbyterian Hospital
Columbia University
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00194987
First received: September 13, 2005
Last updated: June 13, 2013
Last verified: June 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alloimmune Thrombocytopenia Fetal Alloimmune Thrombocytopenia |
Drug: IVIG (Intravenous Immunoglobulin) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia |
Further study details as provided by Weill Medical College of Cornell University:
Primary Outcome Measures:
- To raise the platelet count of affected fetus. [ Time Frame: 20-30 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 3 |
Drug: IVIG (Intravenous Immunoglobulin)
one to two mg per kg once-twice weekly
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194987
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194987
Contacts
| Contact: Megan Wissert, R.N.C. | 212-746-3416 | mwissert@nyp.org |
Locations
| United States, New York | |
| New York Presbyterian Hospital-Weill Cornell Medical Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Megan Wissert, R.N.C. 212-746-3416 mwissert@nyp.org | |
| Principal Investigator: James B Bussel, M.D. | |
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 |
More Information
No publications provided by Weill Medical College of Cornell University
Additional 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 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 Immunoglobulins, Intravenous |
Rho(D) Immune Globulin Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 25, 2015