Role of tranexamic acid-soaked gelatin sponge in minimizing rectus sheath hematoma after cesarean section in women treated with warfarin, a simple tool for high-risk cases, a randomized controlled trial

BACKGROUND: This study aims to illustrate the impact of applying the tranexamic acid impregnated in a gelatin sponge between the anterior rectus sheath and the Rectus Abdominis muscle during Cesarean section (CS) in minimizing rectus sheath hematoma (RHS) in women treated with Warfarin. METHODS: A clinical trial was carried out on 63 pregnant women attended for elective CS, who on antenatal warfarin anticoagulation started from 13 weeks gestation to 36 weeks then shifted to low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH), and with an indication for postnatal warfarin anticoagulation. They were randomly assigned on the day of the scheduled CS into three equal groups (21 women for each). Group 1 had two pieces of gelatin sponges soaked with one ampoule of tranexamic acid. Group 2 had two pieces of gelatin sponges not soaked with tranexamic acid. Group 3 (control group) had no gelatin sponge applied. All patients underwent postoperative assessment done for hemoglobin (Hb), hematocrit (HCT), estimated blood loss (EBL), amount and nature of discharge collected from the sub-rectus drain, complications (RHS, wound infection, thromboembolism), need for re-operation, and need for blood transfusion. RESULTS: Statistically significant differences were found between Group 1 and Group 2 regarding the postoperative Hb (10.66 ± 1.13 vs. 9.77 ± 0.69, P = 0.009), between Group 1 and Group 2 regarding the postoperative HCT (31.87 ± 3.59 vs. 28.54 ± 1.85, P = 0.001), between Group 1 and Group 2 regarding EBL (442.19 ± 244.46 vs. 744.38 ± 267.05, P = 0.003), between Group 1 and Group 3 regarding EBL (442.19 ± 244.46 vs. 664.29 ± 343.97, P = 0.040), and between Group 1 and Group 3 regarding the discharge amount from the sub rectus drain (190.48 ± 100.77 vs. 307.14 ± 127.76, P = 0.004). CONCLUSION: Tranexamic acid-soaked gelatin sponges are safe and effective in reducing postoperative drainage and EBL. Clinical Trial Registration: At ClinicalTrials.gov in June 2022 (NCT05439694).