Drug administration and dosage schedule
STERILE
Women will be randomly allocated to receive:
1 g tranexamic acid as 2 × 5 ml IM injections (100 mg/ml) and slow IV injection of placebo (1 × 10 ml of 0.9% sodium chloride)1 g tranexamic acid by slow IV injection (1 × 10 ml) and 2 × 5 ml IM injections of placeboPlacebo by 1 × slow 10-ml IV injection and 2 × 5 ml IM injectionsIn caesarean births, the trial treatment will be given prior to skin incision, immediately after draping. In vaginal births, the trial treatment will be given at crowning. There should be no delay in administering the trial treatment. Both IM injections should be given first, then the IV injection.For IM administration, the 1 g dose (10 ml) is divided into two 5-ml IM injections to reduce the injection volume (5 ml is considered the upper limit) [Each treatment pack contains clearly labelled IM and IV treatments. The IM treatment kit has two ampoules each containing 500 mg (5 ml) of TXA or placebo and two syringe labels. Two sterile 5-ml syringes and two needles will be provided. The IV treatment kit has two ampoules each containing 500 mg (5 ml) of TXA or placebo and one syringe label. One sterile 10-ml syringe and one needle will be provided. Before administration of IM and IV treatments, the expiry dates should be checked and the randomisation number confirmed. Appropriately qualified staff will prepare and administer the IM treatment first then the IV treatment:IM treatment: Open the IM treatment kit and draw up the contents of each ampoule into each 5-ml syringe using the needles provided. Administer the two 5-ml IM injections first.IV treatment: Open the IV treatment kit and draw up the contents of both ampoules into one 10-ml syringe using the needle provided. Administer one 10-ml injection as a slow intravenous injection at a rate of about 1 ml/min using the usual IV administration procedure, after administering the two IM injections.