The effect of intravenous (IV) tranexamic acid plus buccal misoprostol on blood loss during and after cesarean delivery: a randomized double-blind study
Objective. To investigate the efficacy and safety of tranexamic acid (TA) plus buccal misoprostol versus intravenous oxytocin in reducing bleeding during and after cesarean delivery in women with risk factors for postpartum hemorrhage.
Patients and methods. A randomized clinical trial (NCT03505333) conducted on 400 pregnant women at term (37-40 weeks) gestation, scheduled for elective cesarean delivery, who were assigned to either 1 gm intravenous (IV) tranexamic acid plus buccal misoprostol 400 mcg or intravenous infusion of 20 units of oxytocin after delivery of the neonate. The main outcome measures were blood loss at cesarean section and 6 hours after cesarean delivery, the need for any additional oxytocic drugs, and drug-related side effects.
Results. The overall mean blood loss was significantly lower in the misoprostol group compared to the oxytocin group (863.48 ± 194.95 mL vs 1047.10 ± 290.96 mL; p = 0.0001). There was a need for additional oxytocic therapy in 27% and 57% after the use of misoprostol and oxytocin, respectively (p = 0.0001). The incidence of side effects such as shivering and the metallic taste was significantly higher in the misoprostol group compared to the oxytocin group (p = 0.0001).
Conclusions. IV TA plus buccal misoprostol is more effective than an intravenous infusion of oxytocin in reducing total blood loss during and after cesarean delivery.