Objective

This study aimed to assess the efficacy and safety of prophylactic tranexamic acid administration vs standard uterotonic agents alone among women undergoing cesarean delivery.

Data Sources

MEDLINE, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Google Scholar were systematically searched from inception to June 30, 2021.

Study Eligibility Criteria

Randomized controlled trials comparing intravenous tranexamic acid administration with placebo in women undergoing cesarean delivery and receiving standard prophylactic uterotonic agents were held eligible.

Study Appraisal and Synthesis Methods

The risk of bias of individual studies was appraised with the Risk of Bias 2 tool. Meta-analysis was conducted by fitting random-effects models using restricted maximum likelihood. Subgroup analysis was performed on the basis of country, protocol availability, double-blinding, risk of bias, sample size, and tranexamic acid dose. A 1-stage meta-analysis was performed as a sensitivity analysis. The credibility of outcomes was appraised with the Grading of Recommendations Assessment, Development and Evaluation approach.

Results

Overall, 36 studies with 10,659 women were included. Tranexamic acid administration was associated with significantly lower total blood loss (mean difference, −189.44 mL; 95% confidence intervals, −218.63 to −160.25), lower hemoglobin drop (mean difference, 8.22%; 95% confidence interval, 5.54–10.90), decreased risk of blood loss of >1000 mL (odds ratio, 0.37; 95% confidence interval, 0.22–0.60), transfusion requirement (odds ratio, 0.41; 95% confidence interval, 0.26–0.65), and need of additional uterotonics (odds ratio, 0.36; 95% confidence interval, 0.25–0.52). Subgroup analysis indicated a greater effect of tranexamic acid on total blood loss reduction in low-middle income countries. The outcomes remained stable by separately evaluating women at low bleeding risk. The 1-stage meta-analysis demonstrated similar outcomes with the primary analysis. The quality of evidence was judged to be moderate regarding total blood loss and hemoglobin percentage change and low for the other outcomes.

Conclusion

This meta-analysis suggested that prophylactic tranexamic acid administration is effective among women undergoing cesarean delivery in lowering postpartum blood loss and limiting hemoglobin drop. Further research is needed to test its efficacy in high-risk populations and verify its safety profile.

中文翻译：

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氨甲环酸预防剖宫产妇女产后出血：一项更新的荟萃分析

客观的

本研究旨在评估在接受剖宫产的妇女中预防性使用氨甲环酸与单独使用标准宫缩剂的疗效和安全性。

数据源

从开始到 2021 年 6 月 30 日，系统地检索了 MEDLINE、Scopus、Web of Science、Cochrane Central Register of Controlled Trials、ClinicalTrials.gov 和 Google Scholar。

学习资格标准

在接受剖宫产和接受标准预防性宫缩剂的妇女中比较静脉注射氨甲环酸与安慰剂的随机对照试验符合条件。

研究评估和综合方法

使用偏倚风险 2 工具评估个别研究的偏倚风险。通过使用受限最大似然拟合随机效应模型进行荟萃分析。根据国家、方案可用性、双盲、偏倚风险、样本量和氨甲环酸剂量进行亚组分析。进行一阶段荟萃分析作为敏感性分析。结果的可信度通过建议分级评估、制定和评估方法进行评估。

结果

总体而言，纳入了 36 项研究，涉及 10,659 名女性。氨甲环酸给药显着降低总失血量（平均差，-189.44 mL；95% 置信区间，-218.63 至 -160.25），降低血红蛋白下降（平均差，8.22%；95% 置信区间，5.54-10.90） , 减少 >1000 mL 的失血风险（优势比，0.37；95% 置信区间，0.22–0.60），输血需求（优势比，0.41；95% 置信区间，0.26–0.65）和额外宫缩剂的需求（优势比，0.36；95% 置信区间，0.25–0.52）。亚组分析表明，在中低收入国家，氨甲环酸对减少总失血量的影响更大。通过单独评估低出血风险的女性，结果保持稳定。一阶段荟萃分析显示与主要分析相似的结果。关于总失血量和血红蛋白百分比变化的证据质量被判定为中等，而其他结果的证据质量为低。

结论

这项荟萃分析表明，在接受剖宫产的妇女中，预防性使用氨甲环酸可有效减少产后失血和限制血红蛋白下降。需要进一步的研究来测试其在高危人群中的功效并验证其安全性。