A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

October 9, 2018 updated by: Weill Medical College of Cornell University

A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital-Weill Cornell Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Newborns With a Birth Platelet Count > 50,000/uL
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
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
Time Frame: 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
time of ICH (range 20-40 wks)
Number of Fetal Platelet Counts > 50,000/uL
Time Frame: 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
32 +/- 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Columbia University
New York Presbyterian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (ACTUAL)

June 30, 2015

Study Completion (ACTUAL)

June 30, 2015

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 19, 2005

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0102004801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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