Investigational Medicinial Product (IMP) and Placebo Manufacture - IM Woman Trial

Description

Manufacturing and packing of IMP for the IM Woman Trial due to commence in March 2023. A randomised, triple-blind, three-arm, non-inferiority trial to assess the efficacy and safety of intramuscular tranexamic acid compared to intravenous tranexamic acid and placebo in women having vvaginal and caesarean section births. Three arms include experimental treatment (IM TXA), reference treatment/active control (IV TXA), and placebo control (0.9% sodium chloride solution). Treatment Kit Boxes required 4 campaigns with approximately 10,000 patient packs per campaign. Recruitment period is 24 months - campaign approximately once every 6 months.