A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Phase 3CompletedNCT00194987

Weill Medical College of Cornell University102 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Alloimmune Thrombocytopenia Fetal Alloimmune Thrombocytopenia

Interventions

IVIG (Intravenous Immunoglobulin)DRUG

one gram per kg of IVIG per infusion given either once or twice

prednisoneDRUG

in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

New York Presbyterian Hospital-Weill Cornell Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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 frame: 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

Time frame: 32 +/- 2 weeks

Data from ClinicalTrials.gov

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