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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
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
New York Presbyterian Hospital
Columbia University
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 19, 2005
Results First Submitted Date  ICMJE August 10, 2018
Results First Posted Date  ICMJE November 7, 2018
Last Update Posted Date November 7, 2018
Study Start Date  ICMJE April 2001
Actual Primary Completion Date June 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Number of Newborns With a Birth Platelet Count > 50,000/uL [ Time Frame: 32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40 ]
this uses the birth platelet count of the fetuses from the study when they are born
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00194987 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study [ Time Frame: time of ICH (range 20-40 wks) ]
    number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation
  • Number of Fetal Platelet Counts > 50,000/uL [ Time Frame: 32 +/- 2 weeks ]
    Number of Fetal Platelet Counts > 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
Official Title  ICMJE A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomization between 2 groups
Masking: None (Open Label)
Masking Description:
participants and their physicians will know if they are receiving IVIG x 2 or IVIG x1 plus prednisone
Primary Purpose: Treatment
Condition  ICMJE
  • Alloimmune Thrombocytopenia
  • Fetal Alloimmune Thrombocytopenia
Intervention  ICMJE
  • Drug: IVIG (Intravenous Immunoglobulin)
    one gram per kg of IVIG per infusion given either once or twice
  • Drug: prednisone
    in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day
Study Arms  ICMJE
  • Experimental: IVIG x 2
    IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT
    Intervention: Drug: IVIG (Intravenous Immunoglobulin)
  • Experimental: IVIG x 1 + prednisone
    IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT
    Interventions:
    • Drug: IVIG (Intravenous Immunoglobulin)
    • Drug: prednisone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
102
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 30, 2015
Actual Primary Completion Date June 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00194987
Other Study ID Numbers  ICMJE 0102004801
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE
  • New York Presbyterian Hospital
  • Columbia University
Investigators  ICMJE
Principal Investigator: James B Bussel, M.D. Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP