The effect of prophylactic oral tranexamic acid plus buccal misoprostol on blood loss after vaginal delivery: a randomized controlled trial

Abstract

Objective: The objective of this study is to evaluate the effect of prophylactic oral tranexamic acid (TA) plus buccal misoprostol on the amount of blood loss after vaginal delivery in women at low risk for post-partum hemorrhage (PPH).

Materials and methods: The study was a randomized open label clinical trial conducted in a tertiary University Hospital between January 2016 and June 2017. We included women who delivered vaginally with a singleton pregnancy. They were randomized into three groups: group I (women received 10 IU oxytocin IV after delivery of the baby), group II (women received 600 µg buccal misoprostol after delivery of the baby), and group III (women received 1000 mg oral TA at the end of the first stage of labor plus 600 µg buccal misoprostol after delivery of the baby). In each group, pre- and post-delivery pulse rate, blood pressure, temperature, and hemoglobin level were evaluated. Additionally, the amount of blood loss, need for blood transfusion, need for additional uterotonics, and side effects of the study medications were recorded.

Results: There was a statistically significant lower hemoglobin level and higher blood loss in the misoprostol group compared with oxytocin group and TA plus misoprostol group (p = .0001). There was a statistically significant higher hemoglobin level and lower blood loss in the TA plus misoprostol group compared with the oxytocin group (p = .004 and .043, respectively). PPH occurred in 16.7% of women in the misoprostol group compared 1.7% in the oxytocin group and no cases of PPH in the TA plus misoprostol group (p = .0001).

Conclusions: In settings like rural area or home delivery in which oxytocin is not available, alternative oral TA plus buccal misoprostol may be considered as an effective line in prevention of PPH.

Keywords: Misoprostol; post-partum hemorrhage; tranexamic acid; vaginal delivery.