Trial design {8}
PPH
The I’M WOMAN trial is a parallel, randomised, double-blind, placebo-controlled, three-arm trial comparing the effects of tranexamic acid by the intramuscular and intravenous route with placebo in women with one or more risk factors for PPH giving birth vaginally or by CS. About 30,000 women will be allocated to receive either (a) 1 g of tranexamic acid as two 5-ml IM injections (100 mg/ml) and IV placebo (10 ml 0.9% sodium chloride), (b) 1 g of tranexamic acid by IV injection and two 5-ml IM placebo injections, or (c) matching placebo. An optimal, allocation ratio was used to maximise study power.