Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial.

Methods

Randomised, double blind, placebo controlled, phase 3 study.

随机、双盲、安慰剂对照的III期研究。

24 maternity units across China between July 2023 and March 2025.

2023年7月至2025年3月期间，中国24个产科单位。

1732 women with placenta praevia undergoing caesarean delivery.

1732名患有前置胎盘并接受剖宫产的妇女。

Participants were randomly (1:1) assigned to receive prophylactic oxytocin and either tranexamic acid (1 g in 10 mL) or placebo (10 mL normal saline) diluted in 40 mL normal saline intravenously over 10 minutes, initiated within five minutes of umbilical cord clamping.

参与者被随机分配（1:1），接受预防性催产素治疗，并静脉注射10毫升的氨甲环酸（1克）或安慰剂（10毫升生理盐水），均稀释在40毫升的生理盐水中，滴注时间10分钟，开始于脐带结扎后五分钟内。

The primary outcome was postpartum haemorrhage, defined as calculated estimated blood loss ≥1000 mL or as red cell transfusion within two days after delivery.

主要结果是产后出血，定义为计算出的估计失血量≥1000毫升，或在分娩后两天内接受红细胞输血。

Serious adverse events included thromboembolic events, seizures, acute kidney or liver injury, and maternal death.

严重不良事件包括血栓栓塞事件、癫痫发作、急性肾或肝损伤以及孕产妇死亡。

Results

Of 1732 women with placenta praevia who were randomised, 38 were excluded because they withdrew consent or were determined to be ineligible after randomisation.

在随机分配的1732名胎盘前置的妇女中，有38人因撤回同意或在随机分配后被认为不符合条件而被排除。

Primary outcome data were available for 99.8% (1691/1694) of the remaining women.

剩余女性中有99.8%（1691/1694）可获得主要结果数据。

Placenta accreta spectrum was diagnosed in 303 participants (17.9%).

在303名参与者（17.9%）中诊断出胎盘粘连症。

The primary outcome occurred in 29.7% (251/845) of the tranexamic acid group and 35.1% (297/846) of the placebo group (relative risk 0.85, 95.2% confidence interval(CI) 0.75 to 0.96; P=0.01).

主要结果发生在29.7% (251/845) 的氨甲环酸组和35.1% (297/846) 的安慰剂组（相对风险0.85，95.2%置信区间（CI）0.75至0.96；P=0.01）。

The rates of serious adverse events were similar between the tranexamic acid group and placebo group (0.5% (4 of 837) v 0.5% (4 of 845); relative risk 1.01, 95% CI 0.25 to 4.00).

氨甲环酸组和安慰剂组之间的严重不良事件发生率相似（0.5% (4/837) 对0.5% (4/845)；相对风险1.01，95% CI 0.25至4.00）。

Conclusions

In women with placenta praevia who underwent caesarean delivery and received prophylactic oxytocin, treatment with tranexamic acid resulted in a statistically significant yet modest reduction in the incidenceof postpartum haemorrhage, with no signal of increased serious adverse events.

在接受剖宫产和预防性催产素治疗的前置胎盘女性中，氨甲环酸治疗使得产后出血发生率显著但适度降低，且未见严重不良事件增多的迹象。

trial_registration

ClinicalTrials.gov NCT05811676.

ClinicalTrials.gov NCT05811676。