Fetal or Neonatal Alloimmune Thrombocytopenia
Conditions
Interventions
Study group: low dose IvIG (0.5 g/kg/wk)
Control group, standard treatment: high dose IvIG (1.0 g/kg/wk).
Sponsors
Sanquin Bloodbank Amsterdam provides the trial medication
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women with a subsequent pregnancy after prior pregnancy complicated by HPA alloimmunization who have given birth to a child with a platelet count < 150 x 10 9/l in the first week of life; 2. HPA alloimmunization must have been confirmed by the presence of maternal anti-HPA antibodies and the offending HPA antigen in the fetus 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 fetus 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
Exclusion criteria: 1. Pregnant women with autoimmune thrombocytopenia; 2. Twins or multiple pregnancies; 3. Fetuses and neonates with major congenital anomalies or chromosomal abnormalities; 4. Women who have previously given birth to children with FNAIT with ICH. Women who have antibodies in the first pregnancy (discovered by chance, or for instance with a sister with FNAIT).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of neonates with intracranial hemorrhage. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cord blood platelet count at birth. 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. | — |
Contacts
Public ContactD. Oepkes
Leiden University Medical Center (LUMC), Department of Obstetrics, K6-31, P.O. Box 9600
Outcome results
None listed