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Prophylactic tranexamic acid in Cesarean delivery: an updated meta-analysis with a trial sequential analysis

Acide tranexamique prophylactique pour la césarienne : une méta-analyse mise à jour et une analyse séquentielle des études

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Abstract

Purpose

Postpartum hemorrhage (PPH) is a leading cause of maternal mortality worldwide. Although several studies on the prophylactic use of tranexamic acid (TXA) in parturients undergoing Cesarean delivery have been published, conflicting results raise questions regarding its use. Thus, we aimed to investigate the safety and efficacy of PPH prophylaxis with TXA.

Source

We searched PubMed®, Embase, Cochrane Central, and ClinicalTrials.gov for randomized controlled trials (RCTs) comparing prophylactic TXA with placebo or no treatment in parturients undergoing Cesarean delivery. Our main outcomes were PPH, any blood transfusion, need for additional uterotonics, and adverse events. We performed a trial sequential analysis (TSA) of all outcomes to investigate the reliability and conclusiveness of findings.

Principal findings

We included 38 RCTs including 22,940 parturients, 11,535 (50%) of whom were randomized to receive prophylactic TXA. Patients treated with TXA had significantly fewer cases of PPH (risk ratio [RR], 0.51; 95% confidence interval [CI], 0.38 to 0.69; P < 0.001); less blood transfusion (RR, 0.43; 95% CI, 0.30 to 0.61; P < 0.001), and less use of additional uterotonics (RR, 0.52; 95% CI, 0.40 to 0.68; P < 0.001). No significant differences were found between the groups in terms of adverse effects and thromboembolic events.

Conclusion

Prophylactic TXA administration for parturients undergoing Cesarean delivery significantly reduced blood loss, without increasing adverse events, supporting its use as a safe and effective strategy for reducing PPH in this population.

Study registration

PROSPERO (CRD42023422188); first submitted 27 April 2023.

Résumé

Objectif

L’hémorragie du post-partum (HPP) est l’une des principales causes de mortalité maternelle dans le monde. Bien que plusieurs études sur l’utilisation prophylactique d’acide tranexamique (TXA) chez les personnes parturientes ayant accouché par césarienne aient été publiées, des résultats contradictoires soulèvent des questions quant à son utilisation. Ainsi, nous avons cherché à étudier l’innocuité et l’efficacité de la prophylaxie à base de TXA pour l’HPP.

Sources

Nous avons fait une recherche sur PubMed®, Embase, Cochrane Central et ClinicalTrials.gov pour en tirer les études randomisées contrôlées (ERC) comparant le TXA prophylactique à un placebo ou à l’absence de traitement chez les personnes parturientes accouchant par césarienne. Nos principaux critères d’évaluation étaient l’HPP, toute transfusion sanguine, la nécessité d’un utérotonique supplémentaire et les événements indésirables. Nous avons effectué une analyse séquentielle des études pour tous les résultats afin d’examiner la fiabilité et le caractère concluant des conclusions.

Constatations principales

Nous avons inclus 38 ERC comprenant 22 940 personnes parturientes, dont 11 535 (50 %) ont été randomisées pour recevoir du TXA prophylactique. La patientèle traitée par TXA présentait significativement moins de cas d’HPP (risque relatif [RR], 0,51; intervalle de confiance [IC] à 95 %, 0,38 à 0,69; P < 0,001); moins de transfusion sanguine (RR, 0,43; IC 95 %, 0,30 à 0,61; P < 0,001) et moins d’utilisation d’utérotoniques supplémentaires (RR, 0,52; IC 95 %, 0,40 à 0,68; P < 0,001). Aucune différence significative n’a été constatée entre les groupes en termes d’effets indésirables et d’événements thromboemboliques.

Conclusion

L’administration prophylactique de TXA pour les personnes parturientes accouchant par césarienne a considérablement réduit les pertes de sang sans augmenter les événements indésirables, ce qui soutient son utilisation comme stratégie sécuritaire et efficace pour réduire l’HPP dans cette population.

Enregistrement de l’étude

PROSPERO (CRD42023422188); première soumission le 27 avril 2023.

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Author contributions

Henrique Provinciatto and Sara Amaral contributed to all aspects of this manuscript, including study conception and design; acquisition, analysis, and interpretation of data; and drafting the article. Maria E. Barbalho and Pedro M. da Câmara contributed to the data acquisition and interpretation of data. Isabelle B. Donadon, Luisa M. Fonseca, and Alice D. Marinho contributed to the acquisition of data. Eduardo Sirena contributed to the data analysis. Alexandre Provinciatto contributed to the design and interpretation of data.

Acknowledgments

The authors sincerely thank Dr. Rhanderson Cardoso (Brigham and Women’s Hospital, Harvard Medical School) for his review of the manuscript.

Disclosures

The authors declare no conflicts of interest.

Funding statement

The authors did not receive support from any organization for the submitted work.

Prior conference presentations

This meta-analysis was presented in the category of oral presentation at XXXVII Congresso Latino-americano de Anestesiologia (7–10 September 2023, Rio de Janeiro, Brazil).

Data availability statement

Because this meta-analysis was based on data extracted from previously published research, all the data and study materials are available in the public domain. The authors of this meta-analysis do not have access to patient-level data of the individual studies. Researchers interested in individual-level data from the studies included in this meta-analysis are encouraged to contact the corresponding author from each study with this request.

Editorial responsibility

This submission was handled by Dr. Ronald B. George, Associate Editor, Canadian Journal of Anesthesia/Journal canadien d’anesthésie.

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Authors and Affiliations

  1. Barao de Maua University Center, Avenida Portugal, 2433, Ribeirao Preto, SP, Brazil

    Henrique Provinciatto MD

  2. Potiguar University, Natal, Brazil

    Maria E. Barbalho MD

  3. Federal University of Rio Grande do Norte, Natal, Brazil

    Pedro M. da Câmara MS

  4. University of Buenos Aires, Buenos Aires, Argentina

    Isabelle B. Donadon MS

  5. Faculty of Medical Sciences of Minas Gerais, Belo Horizonte, Brazil

    Luiza M. Fonseca MS

  6. University of Caxias do Sul, Caxias do Sul, Brazil

    Marina S. Bertani MS

  7. Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil

    Alice D. Marinho MS

  8. University of Fortaleza, Fortaleza, Brazil

    Eduardo Sirena MS

  9. Medical Hospital, Limeira, Brazil

    Alexandre Provinciatto MD, PhD

  10. Regional Hospital Deputado Afonso Guizzo, Araranguá, Brazil

    Sara Amaral MD, DESAIC

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Provinciatto, H., Barbalho, M.E., da Câmara, P.M. et al. Prophylactic tranexamic acid in Cesarean delivery: an updated meta-analysis with a trial sequential analysis. Can J Anesth/J Can Anesth 71, 465–478 (2024). https://doi.org/10.1007/s12630-024-02715-3

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