The effect of Intravenous Tranexamic Acid on Blood loss after Vaginal Delivery: A Triple Blind Randomized Controlled Trial.

Abstract

Abstract: Background and Objectives: Postpartum hemorrhage is a major cause of maternal mortality. Therefore, this study aimed to determine the effect of intravenous Tranexamic acid on blood loss after vaginal delivery. Materials and Methods: This triple blind randomized controlled trial was carried out on 120 pregnant women referring to Al Zahra educational and treatment center Tabriz. Subjects were enrolled using convenience sampling and randomly assigned into two intervention and control group of 60 patients. After delivery of the anterior shoulder, the intervention group received one gram intravenous Tranexamic acid and the control group received one gram placebo in 200 ml normal saline over 10 minutes. For measuring estimated blood loss, Blood collection container was placed under the patients' bed. Also a plastic cover and drape were spread under parturient woman immediately after neonate delivery. Differences between the weight of the full and empty container and the dry and bloody plastic cover, drapes and gauze pads were recorded during the first two hours after delivery. Blood loss was measured by the method of Gai et al. Before and 12-24 hours after delivery, the level of hemoglobin and hematocrit of subjects were measured. Calculated blood loss was assessed according to pre –and post-delivery hematocrit. Following delivery of the placenta, 10 units of oxytocin in 500 ml of normal saline was infused intravenously to both groups and the duration of the third stage of labor, neonate and placental weight were recorded. Complications resulting from injection of Tranexamic acid and vital signs were monitored during the first two hours after delivery. SPSS 17 software was used for data analysis and independent t –test, paired t –test, ANOVA, Chi –square tests were used. Results: There was no statistically significant difference between the groups in terms of demographic and reproductive characteristics, and also birth weight, placenta weight, vital signs and side effects. The calculated blood loss was significantly less in the intervention group compared with the control group (p=0.03) and also blood loss from placental delivery to 2 hours postpartum was significantly lower in the intervention group compared with the control group (p<0.001). There was no significant difference between groups in terms of blood loos from baby delivery to 2 hours after birth (p=0.12). Conclusion: The average of blood loss after delivery was less in the intervention group than the control group that shows the effect of Tranexamic acid. Thus, this drug can be used for reducing blood loss for preventing of maternal morbidity and mortality.