The No IntraCranial Haemorrhage (NOICH) Study

Completed

Conditions: Foetal or neonatal alloimmune thrombocytopenia
Pregnancy and Childbirth
Other perinatal haematological disorders

Registration Number: ISRCTN29462550

Lead Sponsor: eiden University Medical Centre (LUMC) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 212

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of neonates with intracranial haemorrhage.

Secondary Outcome Measures

Name	Time	Method
1. Cord blood platelet count at birth<br>2. Other variables studied will be the levels of maternal and neonatal anti-HPA antibodies and IgG, the occurrence of other bleedings in the neonate as well as the necessity and type of neonatal treatment