Contact information
Type
Scientific
Primary contact
Dr D. Oepkes
ORCID ID
Contact details
Leiden University Medical Centre
Department of Obstetrics
K6-31
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5263360
D.Oepkes@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR248
Study information
Scientific title
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
Acronym
NOICH (No IntraCranial Haemorrhage)
Study hypothesis
The hypothesis is that 0.5 g/kg/wk of IvIG is as effective as 1.0 g/kg/wk, in the prevention of intracranial haemorrhage (ICH) in foetal or neonatal alloimmune thrombocytopenia (FNAIT).
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre randomised single-centre active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Foetal or neonatal alloimmune thrombocytopenia
Intervention
Study group: low dose IvIG (0.5 g/kg/wk)
control group: standard treatment: high dose IvIG (1.0 g/kg/wk)
Intervention type
Drug
Phase
Not Applicable
Drug names
Intravenous immunoglobulin (IvIG)
Primary outcome measure
Number of neonates with intracranial haemorrhage.
Secondary outcome measures
1. Cord blood platelet count at birth
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
Overall trial start date
01/01/2005
Overall trial end date
30/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
212
Participant 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)
Recruitment start date
01/01/2005
Recruitment end date
30/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (Netherlands)
Sponsor details
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Sanquin Bloodbank Amsterdam (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list