Prophylactic use of temporary uterine packing combined with topical tranexamic acid reduces blood loss and transfusion requirements in patients undergoing cesarean section: A double-blind, randomized controlled trial

Abstract

Background: since antiquity post-partum haemorrhage (PPH) has been a terrible event for obstetricians. It accounts for 34% of maternal deaths in Africa and developed countries. It complicates 6% of cesarean delivery (CD) and still raising and correlates with increased frequency of caesarean sections, many uterotonic agents have successfully used alone or in combinations for prevention of such catastrophic, but the most effective medication is still up for controversy. Objective: To compare the efficacy and safety of temporary uterine packing combined with topical tranexamic acid (TA) as adjunct for reducing blood loss following an elective cesarean delivery with intravenous tranexamic acid and placebo in women who have at least one risk factor for postpartum hemorrhage. Patients and methods: A double-blind, randomized clinical trial (: NCT03706339) conducted on 450 pregnant women at term (38 – 40 weeks) gestation scheduled for elective cesarean delivery, who were assigned to either intravenous TA, topical TA, or placebo(saline). The main outcome measures were blood loss at and 6 hours after cesarean delivery, the need for any additional oxytoxic drugs, and TA-related side effects. Results: There was a significant decrease in the intraoperative blood loss and total blood loss in both topical TA and IV TA groups compared to placebo group (p=0.0001,0.0001,0.0001,0.0001). Also, the need to extra uterotonics was significant decrease in IV TA group, 9 (6%) patients compared to 33 (22%) patients in placebo group, and 24 (16%) patients in topical TA group, (p=0.0001 and 0.006) respectively. Finally, operative time, hospital stay, postoperative hemoglobin, and post-operative complication showed no significant difference between the three groups (P= 0.276, 0.126, 0.853, 0.955, 1.00, 1.00) respectively. Conclusion: IV TA and temporary uterine packing combined with topical tranexamic acid is more effective than placebo in reducing total blood loss during and after cesarean delivery in women who have at least one risk factor for postpartum hemorrhage, but IV TA more effective.