Blood In Action

• Research type

  Research Study

• Full title

  Blood In Action: Routine pregnancy blood samples for immunity and infection studies

• IRAS ID

  323097

• Contact name

  Edward Mullins

• Contact email

  edward.mullins@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  2 years, 11 months, 30 days

• Research summary

  RATIONALE FOR CURRENT STUDY
  Each year 27,000 serum samples are stored for 2 years by women booking for pregnancy care in NW London from all groups of the diverse population in NW London, close to the UK’s leading travel hub at Heathrow. These represent a unique to investigate current infections and immunity, to track new and emerging infections to inform public health testing policy and to explore new biomarkers for pregnancy otucomes.

  DESIGN
  Platform observational study for infection, immunity and biomarkers using routine maternity serum samples and clinical data for use cases determined by service users, stakeholders and the research team.

  AIMS
  To engage service users, healthcare professionals and health policy professionals in determining use cases for studies using routine maternity blood samples and data.

  OUTCOME MEASURES
  1. Women’s priorities for use of their routine blood samples and data and preference for the design of studies using them
  2. Seroprevalence for infections and sleeping study for future pandemics, initial targets: Polio, Rubella, HTLV. Additional seroprevalence and infection studies to be determined by PPIE and stakeholder engagement. In case of future pandemics, seroprevalence studies for the pandemic organism will be conducted when a validated serological test is available.
  3. Serology and whole-virome screening of booking serum samples before, during and after the COVID 19 pandemic in women with pre-term and term birth
  4. Biomarkers for adverse pregnancy and child health outcomes

  POPULATION
  All women booking for pregnancy care at Imperial College Healthcare NHS trust and depositing a serum sample for storage with North West London Pathology. Initial studies will be conducted on a non-consent anonymised basis. Service user engagement will determine ongoing use of routine samples and the design of prospective studies, consent models and opt outs.

  ELIGIBILITY
  Serum samples will be used if originating from Imperial College Healthcare NHS trust and i) scheduled for routine disposal after 2 years or ii) there is sufficient serum volume to allow for extraction of aliquot for testing and leaving residual adequate for clinical testing if required

  DURATION
  1/5/23 – 30/4/26

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  23/EM/0248

• Date of REC Opinion

  31 Oct 2023

• REC opinion

  Unfavourable Opinion