Population Prevalence and Incident HPA ‐1a Alloimmunisation in Pregnancy: A Prospective, Multi‐Ethnic, Natural History Study
OBJECTIVE: Foetal-neonatal alloimmune thrombocytopaenia (FNAIT) is a rare disease, most commonly caused by maternal alloantibodies to human platelet antigen (HPA)-1a that can result in severe bleeding. The present study was designed to determine the frequency of higher risk for HPA-1a alloimmunisation and development of FNAIT among a racially and ethnically diverse cohort of pregnant women. DESIGN: Longitudinal, prospective, non-interventional, natural history study. SETTING: Conducted across 28 sites in North America and Europe. POPULATION: Pregnant women (≥ 18 years) with no history of FNAIT. METHODS: Blood samples were collected at 10-14 weeks' gestation and a sequential screening algorithm applied: maternal HPA-1a/1b genotyping, human leukocyte antigen [HLA]-DRB3*01:01 allele status, anti-HPA-1a antibody status and foetal HPA-1 genotype. MAIN OUTCOME MEASURES: Number of women at higher risk for HPA-1a alloimmunisation (i.e., those who are HPA-1b/b, HLA-DRB3*01:01 positive, anti-HPA-1a antibody negative and carrying an HPA-1a-positive foetus) that alloimmunise. RESULTS: Of the 14 114 participants screened, 1.7% were HPA-1b/1b genotype, which varied according to race and geography. Of 24 women at higher risk for FNAIT, five were lost to follow-up with no post-partum test for alloimmunisation. At Week 10 post-partum, 2/19 higher risk participants (11%; 95% confidence interval [CI]: 1.3%, 33.1%) demonstrated anti-HPA-1a antibodies, while 17 remained negative. Pre-existing anti-HPA-1a antibodies were identified in 18 other HPA-1bb, DRB3*01:01 positive women at screening. CONCLUSIONS: This prospective study confirms the rarity of a population at higher risk for HPA-1a alloimmunisation and FNAIT, describes the risk among Black and Asian women, and establishes a rigorous methodology to assess for risk of HPA-1a immunisation.
Authors
- Sara Alson (ORCID: https://orcid.org/0000-0003-2885-7818)
- Emilie Vander Haar
- Surabhi Nanda (ORCID: https://orcid.org/0000-0003-3955-1304)
- Russell S. Miller (ORCID: https://orcid.org/0000-0002-9124-390X)
- Helena Litorp (ORCID: https://orcid.org/0000-0001-7164-598X)
- E. J. T. Verweij (ORCID: https://orcid.org/0000-0002-9343-9957)
- E Schleußner
- Vasilis Sitras (ORCID: https://orcid.org/0000-0003-3264-3302)
- Heidi Tiller (ORCID: https://orcid.org/0000-0002-3250-0750)
- Michael P. Bombara
- James B. Bussel (ORCID: https://orcid.org/0000-0002-2884-9247)
- Shauna Williams
- Daniel W. Skupski (ORCID: https://orcid.org/0000-0003-1504-0024)
- Katherine Kohari (ORCID: https://orcid.org/0000-0001-7008-6477)
- Akash Gupta (ORCID: https://orcid.org/0000-0001-6838-2576)
- Dawn Black
- Laura Lawrence (ORCID: https://orcid.org/0009-0009-0990-5299)
- Gwen Allen
- Romy Pothof
- Robin Perry
- Kristy Palomares
- Michael Paidas
- Hector Mendez-Figueroa
- Roisin Armstrong
- Eva Wiberg‐Itzel
- David Dhanraj
- Laura Hart (ORCID: https://orcid.org/0000-0002-4257-5553)
Institutions
- Rutgers, The State University of New Jersey (US)
- Leiden University (NL)
- Uppsala University (SE)
- Oslo University Hospital (NO)
- Sunnybrook Health Science Centre (CA)
- St Thomas' Hospital (GB)
- St. Francis Medical Center (US)
- Saint Peter's University Hospital (US)
- University of Miami (US)
- Lund University (SE)
- Wright State University (US)
- Cornell University (US)
- Columbia University Irving Medical Center (US)
- New York Hospital Queens (US)
- Nordland Hospital Trust (NO)
- Yale University (US)
- Cooper Medical School of Rowan University (US)
- Stockholm South General Hospital (SE)
- Presbyterian Hospital (US)
- Clinical Research Consultants (United States) (US)
- Skåne University Hospital (SE)
- Medical Research Associates (US)
- Applied Behavioral Research (United States) (US)
- The University of Texas Health Science Center (US)
- Friedrich Schiller University Jena (DE)
- UiT The Arctic University of Norway (NO)
- Temple University (US)
Publication Details
- Journal
- BJOG An International Journal of Obstetrics & Gynaecology
- Published
- 2026-09-13
- DOI
- https://doi.org/10.1111/1471-0528.70326
- Primary Topic
- Platelet Disorders and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00