A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Phase 2

Completed

• Conditions: Alloimmune Thrombocytopenia; Fetal Alloimmune Thrombocytopenia
• Interventions: Drug: IVIG (Intravenous Immunoglobulin); Drug: prednisone

• Registration Number: NCT00194987
• Lead Sponsor: Weill Medical College of Cornell University

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 available

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2015-06-30
• Study Completion: 2015-06-30
• Results First Submitted: 2018-08-10
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-09
• Last Update Submitted: 2018-10-09
• Results First Posted: 2018-11-07
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVIG x 2	IVIG (Intravenous Immunoglobulin)	IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT
IVIG x 1 + prednisone	IVIG (Intravenous Immunoglobulin)	IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT
IVIG x 1 + prednisone	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

Primary Outcome Measures

Name	Time	Method
Number of Newborns With a Birth Platelet Count > 50,000/uL	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

Secondary Outcome Measures

Name	Time	Method
Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study	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	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

Trial Locations

Locations (1)

New York Presbyterian Hospital-Weill Cornell Medical Center; 🇺🇸 New York, New York, United States