An economic evaluation of tranexamic acid to prevent postpartum hemorrhage in women with vaginal delivery : the randomized controlled TRAAP trial.

OBJECTIVE To estimate the cost effectiveness of tranexamic acid (TXA) use to prevent postpartum hemorrhage. DESIGN A trial-based economic evaluation. SETTING 15 French university maternity hospitals. POPULATION women enrolled in the TRAAP randomized controlled trial comparing TXA versus placebo in women with vaginal delivery. TRAAP failed to show a reduction in postpartum hemorrhage of at least 500 ml in the intervention arm but evidenced significant lower rates of secondary outcomes related to blood loss METHODS & MAIN OUTCOME MEASURES: We estimated direct medical costs from within-trial hospital resources collected prospectively from the study report form. All resources were costed at their value to the hospital. We estimated incremental cost per incremental hemorrhage averted. RESULTS Among the 4,079 women in the TRAAP trial, data necessary to calculate costs were available for 3,836 (94.0%). The average total costs in the TXA and control groups were €2,278 ±388 and €2,288 ±409 per woman respectively (p= 0.79). In women with postpartum hemorrhage of at least 500 ml (trial primary endpoint), costs were €2,359±354 and €2,409±525 (p=0.14); for provider-assessed clinically significant postpartum hemorrhage and postpartum hemorrhage of at least 1000 ml, costs were respectively €2,316±347 versus €2,381±521 (p=0.22) and €2,321±318versus €2,411±590 (p=0.35) in the tranexamic and placebo groups, respectively. The probabilistic sensitivity analysis showed that the use of TXA had a 65-73% % probability of being cost saving and outcome improving. CONCLUSIONS Our findings support the use of TXA as both bleeding events and cost may be reduced 3 out of 4 times.