Clinical trial NCT00194987: A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
Official title: A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alloimmune Thrombocytopenia
Fetal Alloimmune Thrombocytopenia
Keywords: Alloimmune thrombocytopenia
Fetal alloimmune thrombocytopenia
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
name: Columbia University
First posted: 2005-09-19
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization between 2 groups
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Number of Newborns With a Birth Platelet Count > 50,000/uL
timeFrame: 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
Secondary outcomes:
measure: Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study
timeFrame: time of ICH (range 20-40 wks)
measure: Number of Fetal Platelet Counts > 50,000/uL
timeFrame: 32 +/- 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: James B Bussel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lakkaraja M, Jin JC, Manotas KC, Vinograd CA, Ferd P, Gabor J, Wissert M, Berkowitz RL, McFarland JG, Bussel JB. Blood group A mothers are more likely to develop anemia during antenatal intravenous immunoglobulin treatment of fetal and neonatal alloimmune thrombocytopenia. Transfusion. 2016 Oct;56(10):2449-2454. doi: 10.1111/trf.13779. Epub 2016 Sep 9.
citation: Berkowitz RL, Lesser ML, McFarland JG, Wissert M, Primiani A, Hung C, Bussel JB. Antepartum treatment without early cordocentesis for standard-risk alloimmune thrombocytopenia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):249-55. doi: 10.1097/01.AOG.0000270302.80336.dd.