BACKGROUND 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. METHODS From 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. RESULTS Of 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. CONCLUSION Adjunct use of oral TXA with misoprostol to treat PPH resulted in similar clinical and acceptability outcomes when compared to treatment with misoprostol alone. TRIAL REGISTRATION This trial was registered with ClinicalTrials.gov, number NCT02805426. Registered on 3 September 2016.

中文翻译：

---

一项双盲、随机对照试验，探讨口服氨甲环酸作为产后出血治疗的辅助手段。


背景如果口服氨甲环酸（TXA）能够有效减少患有原发性产后出血的妇女分娩后的失血，那么在肠胃外给药不可行的情况下，可以使用口服氨甲环酸（TXA）。该试验评估了口服 TXA 作为舌下含服米索前列醇的辅助治疗阴道分娩后产后出血 (PPH) 的有效性、安全性和可接受性。方法 2016 年 10 月至 2018 年 1 月，对在塞内加尔和越南四家医院进行阴道分娩的妇女进行了筛查，以纳入试验。诊断为产后出血（定义为失血量≥700毫升）的女性被随机分配接受口服TXA（1950毫克）或安慰剂以及800微克舌下含服米索前列醇。使用校准的手术巾测量产后失血量。记录给药后 2 小时内所有 PPH 病例的失血量。主要结果指标是通过试验方案控制出血而无需进一步治疗的女性比例。次要结局包括严重 PPH 发生率、平均/中位失血量、额外宫缩剂的使用和/或干预措施的副作用以及可接受性。结果 在接受 PPH 治疗的 258 名女性中，128 名接受安慰剂和米索前列醇，130 名接受 TXA 和米索前列醇。两组中仅通过试验药物控制活动性出血且未采取其他干预措施的女性比例相似：安慰剂组 77 人（60.2%）；安慰剂组 77 人（60.2%）； 74 (56.9%) TXA，p = 0.59）。使用其他干预措施来控制出血（包括子宫收缩剂）在各组之间没有显着差异。两组 PPH 诊断时的中位失血量均为 700 毫升。 超过 90% 的 PPH 病例仅由子宫收缩乏力或其他原因共同导致（安慰剂为 92.2%，TXA 为 91.5%），其他原因包括会阴和宫颈撕裂以及胎盘滞留。两组的副作用和可接受性报告相似。结论 与单独使用米索前列醇治疗相比，口服 TXA 联合米索前列醇辅助治疗 PPH 具有相似的临床和可接受性结果。试验注册 该试验已在 ClinicalTrials.gov 注册，编号为 NCT02805426。 2016年9月3日注册。