Intravenous immunoglobulin (IvIG) in the treatment of foetal or neonatal alloimmune thrombocytopenia: a prospective, multicentre, randomised trial comparing 0.5 g and 1.0 g IvIG per kilogram bodyweight per week

eiden University Medical Centre (LUMC) (Netherlands)0 sites212 target enrollmentDecember 20, 2005

Overview

No summary available.

Registry

who.int

Start Date

December 20, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

Female

Sponsor

eiden University Medical Centre (LUMC) (Netherlands)

•1\. Pregnant women with a subsequent pregnancy after prior pregnancy complicated by HPA alloimmunisation who have given birth to a child with a platelet count less than 150 x 10^9/l in the first week of life
•2\. HPA alloimmunisation must have been confirmed by the presence of maternal anti\-HPA antibodies and the offending HPA antigen in the foetus or homozygous partner
•3\. The biological fathers are either homozygous positive for the HPA\-type or heterozygous
•4\. In the case of a heterozygous father the platelet antigen genotype of the foetus will be tested before 28 weeks by amniocentesis
•5\. At inclusion, the pregnancy is an ultrasonographically proven intrauterine singleton pregnancy with a gestational age between 12 and 28 weeks
•6\. All participating patients will give written informed consent after oral and written trial information

•1\. Pregnant women with autoimmune thrombocytopenia
•2\. Twins or multiple pregnancies
•3\. Foetuses and neonates with major congenital anomalies or chromosomal abnormalities
•4\. Women who have previously given birth to children with FNAIT with ICH
•5\. Women who have antibodies in the first pregnancy (discovered by chance, or for instance with a sister with FNAIT)