To help address the role that tranexamic acid may play in reducing intraoperative blood loss during Cesarean section (C-section) in women at high-risk of PPH, investigators in Nigeria conduced a double-blind, placebo-controlled, randomized study. This study enrolled high-risk women (i.e., those who had a previous history of PPH); had coexisting uterine fibroids; had multiple pregnancies; had a previous C-section; the fetus had macrosomnia; placenta previa was present; multiple gestation was observed; and the mother had had preeclampsia or eclampsia and polyhydramnios was noted. Tranexamic acid 1 g (10 mL) in a 20-mL total volume or 20 mL of normal saline (placebo) were administered IV about 10 minutes prior to the onset of surgery. Following delivery, 10 international units of IV oxytocin was administered within 1 minute of delivery to facilitate placental expulsion. If bleeding was present, additional uterotonics, including oxytocin, methylergometrine maleate, or rectal misoprostol, could be administered. Primary atonic PPH was defined as blood loss of >1 L due to uterine atony within the first 24 hours after delivery.
The primary outcome was the mean intraoperative blood loss (measured prior to and 48 hours after C-section surgery) during surgery and change in hematocrit 48 hours postoperatively. Secondary outcomes included the need for additional uterotonics and/or blood transfusion intraoperatively and/or further surgical intervention; incidence of postpartum maternal anemia; and occurrence of adverse events (i.e., nausea, vomiting, thromboembolism, coagulopathy).
Two hundred women (100 in the intervention and control group) were randomized (mean age: 31.92 years). The groups were comparable in sociodemographic factors. The most common high-risk factor in both groups was placenta previa (occurred in 21% of the tranexamic acid group and 25% in the control group), which was not statistically significantly different.
Investigators found that there was significantly less mean blood loss in the tranexamic group compared with placebo (442.94 mL vs. 801.28 mL, P = .001). Postoperative hemoglobin in the treatment group was also significantly higher than in controls (10.39 g/dL vs. 9.67 g/dL, P = .001), although the values were similar preoperatively. The use of additional uterotonics was also significantly less in the tranexamic acid group compared with the placebo group (39.0% vs. 68.0%, P = .001). Most importantly, the incidence of PPH was significantly reduced in the tranexamic acid compared with group that receive normal saline (1.0% vs. 19.0%, P = .001). Adverse events were similar between both groups. A limitation of the study is that the serum hematocrit level was only measured pre–C-section and 48 hours postoperatively, and confounders were not addressed. The researchers concluded that routine use of tranexamic acid during C-section surgery in high-risk women should be encouraged.
While this study supports the U.S. position calling for the increased use of tranexamic acid in the management and prevention of PPH, it is also important to be cognizant of the potential risk of medication error–related deaths that have occurred when tranexamic acid was administered intrathecally during C-section surgery. Safety alerts have been issued by the FDA and World Health Organization about this potentially fatal medication error. Intrathecal administration of tranexamic acid is associated with a 50% mortality rate. As it has done in the past, the Institute for Safe Medication Practices has included tranexamic acid on its 2024 List of High-Alert Medications in Acute Care Settings.
Pharmacists should be aware of the call for increased use of tranexamic acid in the postpartum setting following C-section surgery and should be vanguards for the safe administration of this agent, ensuring that accidental intrathecal administration is avoided.
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