Completed

NCT Number: NCT00194987

A 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).

Completed

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Key information

Conditions

Alloimmune Thrombocytopenia Fetal Alloimmune Thrombocytopenia

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

New York Presbyterian Hospital-Weill Cornell Medical Center

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVIG (Intravenous Immunoglobulin)

Drug

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

Prednisone

Drug

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

Primary outcomes

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

Secondary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

Columbia University
New York Presbyterian Hospital

Registry information

Official study title

A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Important dates

Study start: 2001
Primary completion: 2015
Study completion: 2015
First posted: Sep 19, 2005
Registry last updated: Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.