Level of Adverse pregnancy outcomes in M2 haplotype

• Research type

  Research Study

• Full title

  Assessing the effectiveness of low molecular weight heparin (LMWH) in preventing adverse pregnancy outcomes in carriers of M2 haplotype: A feasibility study

• IRAS ID

  340830

• Contact name

  Shakila Thangaratinam

• Contact email

  s.thangaratinam@liverpool.ac.uk

• Sponsor organisation

  University of Birmingham

• Duration of Study in the UK

  0 years, 3 months, 16 days

• Research summary

  This is a fesibility study looking at testing couples to see whether they are positive for the M2 haplotype. The aims are to:

  - determine the proportion of screened individuals who test positive for the M2 haplotype gene in both males and females
  - assess the willingness of the source population to undergo screening
  - pliot procedures for obtaining informed consent
  - test biosampling methods and laboratory analysis processes

  The study also checks if a simple genetic test for the M2 haplotype, done through saliva or blood samples, is effective in predicting pregnancy outcomes.

  The feasibility study will continue until March 2025. After this time the trial will progress to a randomised controlled trial of whether a blood-thinning medication, called low molecular weight heparin (LMWH), can help prevent complications during pregnancy for individuals with a specific genetic variation called the M2 haplotype. This genetic factor is linked to a higher risk of pregnancy-related issues. This will be subject to the trial securing funding to progress to this stage.

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  25/EM/0006

• Date of REC Opinion

  20 Jan 2025

• REC opinion

  Unfavourable Opinion