Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.noich.org

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 measures

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

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

http://www.lumc.nl/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes