A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Alloimmune Thrombocytopenia; Fetal Alloimmune Thrombocytopenia

Treatments: Drug: IVIG (Intravenous Immunoglobulin); Drug: prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT00194987

0102004801

Details and patient eligibility

About

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).

Enrollment: 102 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

IVIG x 2

Experimental group

Description:

IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT

Treatment:

Drug: IVIG (Intravenous Immunoglobulin)

IVIG x 1 + prednisone

Experimental group

Description:

IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT

Treatment:

Drug: prednisone

Drug: IVIG (Intravenous Immunoglobulin)