{
  "abstract": "Abstract Objective To investigate whether prophylactic tranexamic acid reduces the incidence of postpartum haemorrhage in women with placenta praevia compared with placebo.Design Randomised, double blind, placebo controlled, phase 3 study.Setting 24 maternity units across China between July 2023 and March 2025.Participants 1732 women with placenta praevia undergoing caesarean delivery.Interventions 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.Main outcome measures The primary outcome was postpartum haemorrhage, defined as calculated estimated blood loss ≥1000 mL or as red cell transfusion within two days after delivery. Serious adverse events included thromboembolic events, seizures, acute kidney or liver injury, and maternal death.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. Primary outcome data were available for 99.8% (1691/1694) of the remaining women. Placenta accreta spectrum was diagnosed in 303 participants (17.9%). 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). 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).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 incidence of postpartum haemorrhage, with no signal of increased serious adverse events.Trial registration ClinicalTrials.gov NCT05811676.",
  "authors": [
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Centre for Obstetrics and Gynaecology, Guangdong-Hong Kong-Macao Greater Bay Area Higher Education Joint Laboratory of Maternal-Fetal Medicine, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Lizi Zhang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Centre for Obstetrics and Gynaecology, Guangdong-Hong Kong-Macao Greater Bay Area Higher Education Joint Laboratory of Maternal-Fetal Medicine, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Shilei Bi"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing, China",
        "State Key Laboratory of Female Fertility Promotion, Peking University, Beijing, China"
      ],
      "name": "Lian Chen"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Centre for Obstetrics and Gynaecology, Guangdong-Hong Kong-Macao Greater Bay Area Higher Education Joint Laboratory of Maternal-Fetal Medicine, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Lili Du"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Centre for Obstetrics and Gynaecology, Guangdong-Hong Kong-Macao Greater Bay Area Higher Education Joint Laboratory of Maternal-Fetal Medicine, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Fang He"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Northwest Women’s and Children’s Hospital, Xi’an, Shanxi, China"
      ],
      "name": "Yuan Qiao"
    },
    {
      "affiliations": [
        "Department of Obstetrics, The Tenth Affiliated Hospital, Southern Medical University (Dongguan People’s Hospital), Dongguan Key Laboratory of Major Diseases in Obstetrics and Gynaecology, Dongguan, Guangdong, China"
      ],
      "name": "Zhongjun Li"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"
      ],
      "name": "Wanjiang Zeng"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China"
      ],
      "name": "Xianlan Zhao"
    },
    {
      "affiliations": [
        "Tianjin Central Hospital of Obstetrics and Gynaecology, Tianjin, China"
      ],
      "name": "Xu Chen"
    },
    {
      "affiliations": [
        "Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Shenzhen, Women and Children’s Medical Centre, Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Shenzhen, Guangdong, China"
      ],
      "name": "Xiaotian Li"
    },
    {
      "affiliations": [
        "Xinjiang Clinical Research Centre for Perinatal Diseases, Department of Obstetrics and Gynaecology, Urumqi Maternal and Child Health Hospital, Urumqi, Xinjiang, China"
      ],
      "name": "Guifeng Ding"
    },
    {
      "affiliations": [
        "Chongqing Health Centre for Women and Children, Women and Children’s Hospital of Chongqing Medical University, Chongqing, China"
      ],
      "name": "Wei Zhou"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Shenzhen Baoan Women’s and Children’s Hospital, Shenzhen, Guangdong, China"
      ],
      "name": "Bo Sun"
    },
    {
      "affiliations": [
        "Shijiazhuang Obstetrics and Gynaecology Hospital, Hebei Key Laboratory of Maternal and Fetal Medicine, Shijiazhuang, Hebei, China"
      ],
      "name": "Qing Guo"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Foshan Women and Children Hospital, Foshan, Guangdong, China"
      ],
      "name": "Xiaoling Guo"
    },
    {
      "affiliations": [
        "Zhuhai Centre for Maternal and Child Health Care, Department of Obstetrics and Gynaecology, Zhuhai Women and Children’s Hospital, Zhuhai, Guangdong, China"
      ],
      "name": "Fengmei Jin"
    },
    {
      "affiliations": [
        "Key Laboratory of Maternal and Fetal Medicine of National Health Commission of China, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China"
      ],
      "name": "Xietong Wang"
    },
    {
      "affiliations": [
        "Department of Obstetrics, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China"
      ],
      "name": "Qiying Zhu"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Dalian Women and Children’s Medical Group, Dalian, Liaoning, China"
      ],
      "name": "Qiang Sun"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Huadu District People’s Hospital of Guangzhou, Guangzhou, Guangdong, China"
      ],
      "name": "Shaoqing Jiang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Dongguan Maternal and Child Health Care Hospital, Dongguan, Guangdong, China"
      ],
      "name": "Xinghe Wang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Boai Hospital of Zhongshan, Zhongshan, Guangdong, China"
      ],
      "name": "Fenge Cai"
    },
    {
      "affiliations": [
        "Obstetrics Department, Hunan Provincial Maternal and Child Health Care Hospital, Changsha, Hunan, China"
      ],
      "name": "Yurong Jiang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, National Clinical Research Centre for Obstetric and Gynaecologic Diseases, Beijing, China"
      ],
      "name": "Jinsong Gao"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Centre for Obstetrics and Gynaecology, Guangdong-Hong Kong-Macao Greater Bay Area Higher Education Joint Laboratory of Maternal-Fetal Medicine, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Zhijian Wang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Guangdong Provincial Clinical Research Centre for Obstetrics and Gynaecology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China"
      ],
      "name": "Zilian Wang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Lanzhen Zhang"
    },
    {
      "affiliations": [
        "State Key Laboratory of Female Fertility Promotion, Peking University, Beijing, China",
        "Institute of Reproductive and Child Health, National Health Commission Key Laboratory of Reproductive Health, Peking University Health Science Centre, Beijing, China"
      ],
      "name": "Jian-meng Liu"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Liping Huang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Centre for Obstetrics and Gynaecology, Guangdong-Hong Kong-Macao Greater Bay Area Higher Education Joint Laboratory of Maternal-Fetal Medicine, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Lin Yu"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Centre for Obstetrics and Gynaecology, Guangdong-Hong Kong-Macao Greater Bay Area Higher Education Joint Laboratory of Maternal-Fetal Medicine, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Jingsi Chen"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Centre for Obstetrics and Gynaecology, Guangdong-Hong Kong-Macao Greater Bay Area Higher Education Joint Laboratory of Maternal-Fetal Medicine, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China"
      ],
      "name": "Shuang Zhang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, China"
      ],
      "name": "Liona C Poon"
    },
    {
      "affiliations": [
        "State Key Laboratory of Female Fertility Promotion, Peking University, Beijing, China",
        "Institute of Reproductive and Child Health, National Health Commission Key Laboratory of Reproductive Health, Peking University Health Science Centre, Beijing, China"
      ],
      "name": "Hong-tian Li"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynaecology, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Centre for Obstetrics and Gynaecology, Guangdong-Hong Kong-Macao Greater Bay Area Higher Education Joint Laboratory of Maternal-Fetal Medicine, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China",
        "Obstetrics and Gynaecology Centre, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China"
      ],
      "name": "Dunjin Chen"
    },
    {
      "affiliations": [],
      "name": "on behalf of the study’s collaborator group"
    }
  ],
  "title": "Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial",
  "uid": "61f42ff9-f379-535d-a838-a460463de75e"
}