Effects of tranexamic acid preconditioning on the incidence of postpartum haemorrhage in vaginal deliveries with identified risk factors in China: a prospective, randomized, open-label, blinded endpoint trial.
Ann Med
; 56(1): 2389302, 2024 Dec.
Article
en En
| MEDLINE
| ID: mdl-39129492
ABSTRACT
OBJECTIVE:
This study aimed to evaluate the effects of tranexamic acid (TXA) in preventing postpartum haemorrhage (PPH) among women with identified risk factors for PPH undergoing vaginal delivery in China.METHODS:
This prospective, randomized, open-label, blinded endpoint (PROBE) trial enrolled 2258 women with one or more risk factors for PPH who underwent vaginal delivery. Participants were randomly assigned in a 11 ratio to receive an intravascular infusion of 1 g TXA or a placebo immediately after the delivery of the infant. The primary outcome assessed was the incidence of PPH, defined as blood loss ≥500 mL within 24 h after delivery, while severe PPH was considered as a secondary outcome and defined by total blood loss ≥1000 mL within 24 h.RESULTS:
2245 individuals (99.4%) could be followed up to their primary outcome. PPH occurred in 186 of 1128 women in the TXA group and in 215 of 1117 women in the placebo group (16.5% vs. 19.2%; RR, 0.86; 95% CI, 0.72 to 1.02; p = 0.088). Regarding secondary outcomes related to efficacy, women in the TXA group had a significant lower rate of severe PPH than those in the placebo group (2.7% vs. 5.6%; RR, 0.49; 95% CI, 0.32 to 0.74; p = 0.001; adjusted p = 0.002). Similarly, there was a significant reduction in the use of additional uterotonic agents (7.8% vs. 15.6%; RR, 0.50; 95% CI, 0.39 to 0.63; p < 0.001; adjusted p = 0.001). No occurrence of thromboembolic events and maternal deaths were reported in both groups within 30 days after delivery.CONCLUSIONS:
In total population with risk factors for PPH, the administration of TXA following vaginal delivery did not result in a statistically significant reduction in the incidence of PPH compared to placebo; however, it was associated with a significantly lower incidence of severe PPH.
Prophylactic administration of TXA did not yield a statistically significant reduction in the incidence of PPH among women with risk factors in vaginal deliveries.Prophylactic use of TXA may help to reduce the incidence of severe PPH.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Ácido Tranexámico
/
Parto Obstétrico
/
Hemorragia Posparto
/
Antifibrinolíticos
Límite:
Adult
/
Female
/
Humans
/
Pregnancy
País/Región como asunto:
Asia
Idioma:
En
Revista:
Ann Med
Asunto de la revista:
MEDICINA
Año:
2024
Tipo del documento:
Article
País de afiliación:
China
Pais de publicación:
Reino Unido