Abstract | INTRODUCTION: METHODS AND ANALYSIS: The HIP (HPA-screening in pregnancy) study is a nationwide, prospective and observational cohort study aimed to assess incidence and natural history of FNAIT as well as identifying pregnancies at high risk for developing bleeding complications. For logistic reasons, we invite rhesus D-negative or rhesus c-negative pregnant women, who take part in the Dutch population-based prenatal screening programme for erythrocyte immunisation, to participate in our study. Serological HPA-1a typing is performed and a luminex-based multiplex assay will be performed for the detection of anti-HPA-1a antibodies. Results will not be communicated to patients or caregivers. Clinical data of HPA-1a negative women and an HPA-1a positive control group will be collected after birth. Samples of HPA-1a immunised pregnancies with and without signs of bleeding will be compared with identify parameters for identification of pregnancies at high risk for bleeding complications. ETHICS AND DISSEMINATION: Ethical approval for this study has been obtained from the Medical Ethical Committee Leiden-The Hague-Delft (P16.002). Study enrolment began in March 2017. All pregnant women have to give informed consent for testing according to the protocol. Results of the study will be disseminated through congresses and publication in relevant peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04067375.
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Authors | Dian Winkelhorst, Thijs W de Vos, Marije M Kamphuis, Leendert Porcelijn, Enrico Lopriore, Dick Oepkes, C Ellen van der Schoot, Masja de Haas |
Journal | BMJ open
(BMJ Open)
Vol. 10
Issue 7
Pg. e034071
(07 20 2020)
ISSN: 2044-6055 [Electronic] England |
PMID | 32690731
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. |
Chemical References |
- Antigens, Human Platelet
- Isoantibodies
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Topics |
- Antigens, Human Platelet
(immunology)
- Female
- Humans
- Incidence
- Infant, Newborn
- Isoantibodies
(blood)
- Maternal Serum Screening Tests
- Observational Studies as Topic
- Pregnancy
- Prenatal Care
- Prospective Studies
- Research Design
- Risk Assessment
- Thrombocytopenia, Neonatal Alloimmune
(blood, diagnosis)
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