Abstract
BackgroundOral tranexamic acid (TXA), if effective in reducing blood loss after delivery for women experiencing primary PPH, could be administered where parenteral administration is not feasible. This trial assessed the efficacy, safety, and acceptability of oral TXA when used as an adjunct to sublingual misoprostol to treat postpartum hemorrhage (PPH) following vaginal delivery.MethodsFrom October 2016 to January 2018, women presenting at four hospitals in Senegal and Vietnam for vaginal delivery were screened for enrollment in the trial. Women diagnosed with postpartum hemorrhage (defined as blood loss ≥700 ml) were randomized to receive either oral TXA (1950 mg) or placebo in addition to 800 mcg sublingual misoprostol. Postpartum blood loss was measured using a calibrated drape. Blood loss for all PPH cases was recorded for 2 h after administration of the drugs. The primary outcome measure was the proportion of women with bleeding controlled with the trial regimen without recourse to further treatment. Secondary outcomes including the rate of severe PPH, mean/median blood loss, use of additional uterotonics and/or interventions side effects, and acceptability were also recorded.ResultsOf the 258 women who received treatment for PPH, 128 received placebo and misoprostol and 130 received TXA and misoprostol. The proportion of women who had active bleeding controlled with trial drugs alone and no additional interventions was similar in both groups: 77(60.2%) placebo; 74 (56.9%) TXA, p = 0.59). Use of other interventions to control bleeding, including uterotonics, did not differ significantly between groups. Median blood loss at PPH diagnosis was 700 ml in both groups. Uterine atony alone or in addition to another cause contributed to over 90% of PPH cases reported (92.2% placebo vs. 91.5% TXA), other causes included perineal and cervical lacerations and retained placenta. Reports of side effects and acceptability were similar in the two groups.ConclusionAdjunct use of oral TXA with misoprostol to treat PPH resulted in similar clinical and acceptability outcomes when compared to treatment with misoprostol alone.Trial registrationThis trial was registered with ClinicalTrials.gov, number NCT02805426. Registered on 3 September 2016.
Highlights
Obstetric hemorrhage contributes to approximately 25% of maternal deaths worldwide [1]
The findings suggest that the addition of oral tranexamic acid (TXA) did not confer any substantial advantage in treating primary postpartum hemorrhage (PPH) when compared to treatment with misoprostol alone
Among women who received placebo, active bleeding was controlled without recourse to additional interventions in 77 (60.2%) of cases compared to 74 (56.9%) in the TXA group (p = 0.59) (Table 2) RR = 0.936, 95% CI 0.734–1.194) Of the women who received interventions in addition to the trial regimen, approximately one-third received additional uterotonics (placebo: 39 (30.5%); TXA treatment: 45 (34.6%) p = 0.51) (Table 2)
Summary
Obstetric hemorrhage contributes to approximately 25% of maternal deaths worldwide [1]. The two drug regimen of oral TXA and misoprostol might improve the efficacy of treatment of PPH in low resource settings, where a large proportion of deaths from PPH occur [1] This trial aimed to assess the proportion of women with bleeding controlled when oral tranexamic acid is used in conjunction with misoprostol for treatment of PPH. Oral tranexamic acid (TXA), if effective in reducing blood loss after delivery for women experiencing primary PPH, could be administered where parenteral administration is not feasible. This trial assessed the efficacy, safety, and acceptability of oral TXA when used as an adjunct to sublingual misoprostol to treat postpartum hemorrhage (PPH) following vaginal delivery
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