Tranexamic acid versus oxytocin prophylaxis in reducing post-partum blood loss, in low-risk pregnant women: TRANOXY STUDY, a phase III randomized clinical trial.

Autor:	Ragusa A; Department of Obstetrics and Gynecology, Maggiore Hospital Carlo Alberto Pizzardi Bologna, Italy., Ficarola F; Unit of Gynecology, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy.; Unit of Gynecology, Department of Surgical and Medical Sciences and Translational Medicine, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy., Ferrari A; Institute of Management, MeS (Management and Health) Laboratory, Sant'Anna School of Advanced Studies, Pisa, Italy., Spirito N; Department of Obstetrics and Gynecology, Ospedale Apuane, Massa Carrara, Italy., Ardovino M; Department of Obstetrics and Gynecology, Ospedale S.G. Moscati, Avellino, Italy., Giraldi D; Department of Obstetrics and Gynecology, Ospedale S.G. Moscati, Avellino, Italy., Stuzziero E; Department of Obstetrics and Gynecology, Ospedale S.G. Moscati, Avellino, Italy., Rinaldo D; Department of Obstetrics and Gynecology, ASST Bergamo Est, Bolognini Hospital, Seriate, Italy., Procaccianti R; Department of Gynecology and Obstetrics, Fondazione Istituto San Raffaele G Giglio, Cefalù, Italy., Larciprete G; Department of Obstetrics and Gynecology, Fatebenefratelli Gemelli Hospital, Isola Tiberina, Roma, Italy., De Luca C; Department of Obstetrics and Gynecology, Fatebenefratelli Gemelli Hospital, Isola Tiberina, Roma, Italy., D'Avino S; Department of Obstetrics and Gynecology, Fatebenefratelli Gemelli Hospital, Isola Tiberina, Roma, Italy., Principi G; Department of Obstetrics and Gynecology, University of Messina, Messina, Italy., Angioli R; Unit of Gynecology, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy., Svelato A; Department of Obstetrics and Gynecology, Fatebenefratelli Gemelli Hospital, Isola Tiberina, Roma, Italy.
Jazyk:	angličtina
Zdroj:	EClinicalMedicine [EClinicalMedicine] 2024 May 31; Vol. 73, pp. 102665. Date of Electronic Publication: 2024 May 31 (Print Publication: 2024).
DOI:	10.1016/j.eclinm.2024.102665
Abstrakt:	Background: To assess the equivalence of tranexamic acid (TRAN) versus synthetic oxytocin (OXY) in reducing post-partum blood loss, in full-term patients (37-42 weeks), at low risk of post-partum hemorrhage, with vaginal childbirth. Methods: Phase III, randomized (1:1), open-label, longitudinal, multi-center, prospective clinical trial (Prot. n 63209, ClinicalTrials.gov Identifier: NCT02775773). From January 7, 2020, to June 30, 2023, a total of 256 women were enrolled at two general urban community hospitals in Italy, serving a multi-ethnic patient population with National Health Insurance. The primary outcome was to explore a potential equivalence between the two treatments (OXY and TRAN) in preventing total blood loss. Therefore, we randomized 231 women into two groups: Group A (OXY), 127 women who were administered 10UI intramuscularly within 5 min from childbirth; Group B (TRAN), 104 women to whom 1-g slow intravenous infusion was administered within 5 min from childbirth. Findings: At the time of delivery, mean blood loss for OXY group versus TRAN group was 269.12 mL versus 263.88 mL, respectively, with equivalence between the two groups. Similarly, there was equivalence in total blood loss between the OXY and the TRAN group (397.66 mL versus 405.64 mL, respectively. No statistical differences between Hb levels at admission and discharge in the two groups were reported. No difference was found in terms of additional uterotonic and surgical therapies between the two groups of patients. Neither group showed thrombotic complications at check-up performed after 7 days or after a questionnaire regarding adverse effects, subjected after 40 days. Interpretation: The study shows the equivalence of tranexamic acid versus synthetic oxytocin in post-partum blood loss prophylaxis in term patients at low risk of PPH with vaginal childbirth. The safety profiles of OXY and TRAN were similar. Funding: None. Competing Interests: We declare no competing interests. (© 2024 The Author(s).)
Databáze:	MEDLINE
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