Efficacy of intravenous tranexamic acid before cesarean section in preventing post partum hemorrhage- a prospective randomised double blind placebo controlled study

Abstract

Aims- The aim was to evaluate efficacy and safety of intravenous tranexamic acid administered immediately before cesarean section to reduce postpartum hemorrhage. Methods- A prospective, randomized, double blind, placebo controlled study. Inclusion criteria were women with 38-40 weeks of gestation undergoing elective cesarean section. Exclusion criteria were women having risk factors for post partum hemorrhage; previous history of intra abdominal surgery; active thromboembolic disease; cardiovascular, renal or liver disorders and hypersensitivity to tranexamic acid. Participants were randomly assigned to tranexamic acid group (n=70) and placebo group (n=70).Study group received 1 gram of intravenous tranexamic acid just before skin incision, placebo group received 10 ml of sterile water for injection intravenously at the same time. Primary outcome measures were blood loss from delivery of the placenta to the end of the cesarean section, blood loss from the end of cesarean section to 2 hours post partum, difference between pre operative and 24 hours post operative hemoglobin concentration. Secondary outcome measures were need for additional uterotonics or additional surgical interventions to control post partum hemorrhage, amount of fluid infused, need for blood transfusion, mild side effects such as nausea, vomiting and maternal death or severe maternal morbidity such as seizure, thromboembolic events. Results- Blood losses from both placental deliveries to the end of cesarean section and from end of cesarean section to 2 hours postpartum were significantly lower in the study group. (p < 0.0001), change in hemoglobin concentration in study group was also significantly less than in the control group. (p< 0.0001). Total amount of oxytocin required and number of women requiring other oxytocics were significantly less in tranexamic acid group (p= 0.0078). Conclusion- Intravenous bolus administration of tranexamic acid 1 gram before skin incision was found to be effective and safe in preventing post partum hemorrhage in cesarean delivery