A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Conditions
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Alloimmune Thrombocytopenia, Fetal Alloimmune Thrombocytopenia

Intervention / Treatment
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* Drug: IVIG (Intravenous Immunoglobulin)
* Drug: prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomization between 2 groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVIG x 2<br>IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT | Drug: IVIG (Intravenous Immunoglobulin)<br>* one gram per kg of IVIG per infusion given either once or twice<br>|
| Experimental: IVIG x 1 + prednisone<br>IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT | Drug: IVIG (Intravenous Immunoglobulin)<br>* one gram per kg of IVIG per infusion given either once or twice<br>Drug: prednisone<br>* in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Newborns With a Birth Platelet Count > 50,000/uL | this uses the birth platelet count of the fetuses from the study when they are born | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study | 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 | time of ICH (range 20-40 wks) | 
| Number of Fetal Platelet Counts > 50,000/uL | Number of Fetal Platelet Counts > 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined | 32 +/- 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alloimmune thrombocytopenia, Fetal alloimmune thrombocytopenia