Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa
NCT ID: NCT05811676
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1732 participants
INTERVENTIONAL
2023-07-12
2025-03-23
Brief Summary
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studies had poor quality and lacked adequate power to assess severe adverse events.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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study group
Intravenous administration of 10 mL (1 g of tranexamic acid) diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration
Tranexamic acid
Intravenous administration of 10 mL (1 g of tranexamic acid), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration
control group
Intravenous administration of 10 mL placebo (0.9% sodium chloride), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration
0.9% sodium chloride
Intravenous administration of 10 mL placebo(0.9% sodium chloride), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration
Interventions
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Tranexamic acid
Intravenous administration of 10 mL (1 g of tranexamic acid), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration
0.9% sodium chloride
Intravenous administration of 10 mL placebo(0.9% sodium chloride), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Placenta previa before cesarean delivery by ultrasound（Placenta previa defined by a placental edge below 20mm from internal cervical os diagnosed at the most recent transvaginal ultrasound examination before delivery）
* Gestational age ≥ 34 weeks
* Available venous hematocrit value in the week before the cesarean
* Prenatal hemoglobin level in the week before the cesarean \> 90 g/l
* Undergoing cesarean delivery
* Signed informed consent
Exclusion Criteria
* History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial thrombosis (angina pectoris, myocardial infarction, or stroke)
* History of epilepsy or seizure
* Any known active cancer, active cardiovascular, renal, or liver disorders
* Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease
* Sickle cell disease
* Severe hemorrhagic disease
* Administration of low-molecular-weight heparin or antiplatelet agents within one week prior to delivery
* Severe coagulation disorders with prothrombin time or activated partial thromboplastin time exceeding the upper limit of normal, or platelet count less than 80×109/L
* placenta abruption
* In-utero fetal death
* Eclampsia or HELLP syndrome
* Acquired color vision deficiency or subarachnoid hemorrhage
* Severe bleeding with estimated blood loss exceeding 500 ml, within 12 hours before cesarean delivery
* Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome
* Participation in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism or the study intervention potentially affects postpartum bleeding or thromboembolism
18 Years
55 Years
FEMALE
Yes
Sponsors
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Dongguan Maternal and Child Health Care Hospital
UNKNOWN
Foshan Women's and Children's Hospital
OTHER
BoAi Hospital of Zhongshan
OTHER
Women and Children's Hospital of Chongqing Medical University
UNKNOWN
Tianjin Central Hospital of Gynecology Obstetrics
OTHER
Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan
UNKNOWN
Urumqi Maternal and Child Health Care Hospital
UNKNOWN
Zhuhai Women and Children's Hospital
UNKNOWN
The First Affiliated Hospital of Zhengzhou University
OTHER
Hunan Provincial Maternal and Child Health Care Hospital
OTHER
Dalian women and children's medical group
UNKNOWN
Nanfang Hospital, Southern Medical University
OTHER
Huadu District People's Hospital of Guangzhou
OTHER
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Shenzhen Maternity & Child Healthcare Hospital
OTHER
Shenzhen Baoan Women's and Children's Hospital
UNKNOWN
Dongguan People's Hospital
OTHER_GOV
First Affiliated Hospital of Xinjiang Medical University
OTHER
Tongji Hospital
OTHER
Peking Union Medical College
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Fifth Affiliated Hospital of Guangzhou Medical University
OTHER
Shijiazhuang Obstetrics and Gynecology Hospital
OTHER
Guangzhou Medical University
OTHER
Responsible Party
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Dunjin Chen
Department of Obstetrics and Gynecology, The Third Affiliated Hospital
Locations
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Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Peking Union Medical College
Beijing, , China
Peking University First Hospital
Beijing, , China
Women and Children's Hospital of Chongqing Medical University
Chongqing, , China
Dalian Women and Children's Medical Group
Dalian, , China
Dongguan Maternal and Child Health Care Hospital
Dongguan, , China
The Tenth Affiliated Hospital of Southern Medical University; Dongguan People's Hospital
Dongguan, , China
Foshan Women and Children Hospital
Foshan, , China
Boai Hospital of Zhongshan
Guangzhou, , China
Huadu District People's Hospital of Guangzhou
Guangzhou, , China
Nanfang Hospital, Southern Medical University, Guangzhou
Guangzhou, , China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
The first Affiliated Hospital, Sun Yat-sen University
Guangzhou, , China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Zhuhai Women and Children's Hospital
Guangzhou, , China
Obstetrics Department, the Maternal and Child Health Hospital of Hunan Province
Hunan, , China
Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University
Jinan, , China
Shenzhen Baoan Women's and Children's Hospital
Shenzhen, , China
Shenzhen Maternal ＆ Child Healthcare Hospital Affiliated Southern Medical University
Shenzhen, , China
Shijiazhuang Obstetrics and Gynecology Hospital
Shijiazhuang, , China
Tianjin Central Hospital of Gynecology Obsterics
Tianjin, , China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Northwest Women's and Children's Hospital
Xi'an, , China
First Affiliated Hospital of Xinjiang Medical University
Xinjiang, , China
Urumqi Maternal and Child Health Care Hospital
Xinjiang, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Other Identifiers
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MR-44-23-016012（TRAPP）
Identifier Type: -
Identifier Source: org_study_id
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