Comparative evaluation of two doses of tranexamic acid used prophylactically in anemic parturients for lower segment cesarean section: A double-blind randomized case control prospective trial

Abstract

Background: Postpartum hemorrhage (PPH) and anemia thereafter can be a life threatening condition in parturients undergoing lower segment cesarean section (LSCS), especially when anemia is present.

Aim: The objective of this study was to assess two doses of Tranexamic acid (TXA) in reducing intra operative blood loss and incidence of PPH, in terms of both efficacy and safety profiles, when used prophylactically.

Methods: A monocenter prospective case control double blind randomized study was carried out on a consecutive series of 90 anemic patients undergoing LSCS, with hemoglobin between 7-10 g percent. Three random groups were formed. Group T1 (n=30) received 10mg/kg TXA in 20 ml of 5% dextrose intravenously, while T2 group (n=30) received 15mg/kg. Group C (n=30) received a placebo. Drug was administered prophylactically 20 min before skin incision. Blood loss was measured from placental delivery up to 24 hours by method of weight and volume.

Staistical analysis: To compare quantitative data between two groups, t-test, and for more than two groups ANOVA was used. To compare the mean for non- parametric data between two groups Mann - Whitney test was used, while in case of more than two groups Kruskal - Wallis test was employed. Probability (p) value was considered significant when it was 0.05 or less.

Results: TXA significantly reduced blood loss in both the study groups. Mean total blood loss was 527.17±88.666 ml, 376.83±31.961ml and 261.17±56.777 ml in group C, T1, and T2 respectively. While reduction of blood loss in T1 group compared to control group was 146.34±56.32ml, it was 262±31.51ml in T2 group. Difference between T1 and T2 was 115.66±24.81ml, which was statistically significant (P<0.05). Postoperative blood loss was insignificant in all three groups. Pre- and post-operative hemoglobin levels differed significantly when compared to control group. Blood transfusion was needed in two patients in the control group, whereas no patient in groups T1 and T2 needed transfusion (P=0.02). No significant adverse effect was seen in all the three groups.

Conclusion: Hence, TXA was found to be effective in reducing blood loss and transfusion in anemic parturients undergoing LSCS. 15mg/kg dose of TXA was more efficacious than the 10mg/kg dose and without any undue increase in adverse events. Postpartum anemia is a public health problem worldwide and TXA could prove to be a very useful drug to prevent blood loss and transfusions in patients undergoing LSCS, especially in the anemic subgroup.

Keywords: Anemia; blood sparing; lower segment cesarean section; postpartum haemorrhage; tranexamic acid.

Figure 1

% Change in Hemoglobin from pre- to post-operative period. Gr-C – Group C, Gr-T1 – Group T1, Gr-T2 – Group T2