Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa (TRAPP)

Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, PR China

Many RCT(randomized controlled trial) studies reported that tranexamic acid reduced blood loss in women who had elective cesareans. However, most of these elective cesareans are without high-risk factors of postpartum hemorrhage, such as placenta previa. The prophylactic use of tranexamic acid in the placenta previa is not clear.

studies had poor quality and lacked adequate power to assess severe adverse events.

Study Overview

• Status: Completed
• Conditions: Hemorrhage, Postpartum; Placenta Previa
• Intervention / Treatment: Drug: Tranexamic acid; Other: 0.9% sodium chloride

• Study Type: Interventional
• Enrollment (Actual): 1732
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Peking Union Medical College
  • Chongqing, China
    • Women and Children's Hospital of Chongqing Medical University
  • Dalian, China
    • Dalian women and children's medical group
  • Dongguan, China
    • Dongguan Maternal and Child Health Care Hospital
  • Dongguan, China
    • The Tenth Affiliated Hospital of Southern Medical University; Dongguan People's Hospital
  • Foshan, China
    • Foshan Women and Children Hospital
  • Guangzhou, China
    • The First Affiliated Hospital, Sun Yat-Sen University
  • Guangzhou, China
    • The First Affiliated Hospital of Guangzhou Medical University
  • Guangzhou, China
    • The Second Affiliated Hospital of Guangzhou Medical University
  • Guangzhou, China
    • The Fifth Affiliated Hospital of Guangzhou Medical University
  • Guangzhou, China
    • Boai Hospital of Zhongshan
  • Guangzhou, China
    • Huadu District People's Hospital of Guangzhou
  • Guangzhou, China
    • Nanfang Hospital, Southern Medical University, Guangzhou
  • Guangzhou, China
    • Zhuhai Women and Children's Hospital
  • Hunan, China
    • Obstetrics Department, the Maternal and Child Health Hospital of Hunan Province
  • Jinan, China
    • Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University
  • Shenzhen, China
    • Shenzhen Baoan Women's and Children's Hospital
  • Shenzhen, China
    • Shenzhen Maternal ＆ Child Healthcare Hospital Affiliated Southern Medical University
  • Shijiazhuang, China
    • Shijiazhuang Obstetrics and Gynecology Hospital
  • Tianjin, China
    • Tianjin Central Hospital of Gynecology Obsterics
  • Wuhan, China
    • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Xi'an, China
    • Northwest Women's and Children's Hospital
  • Xinjiang, China
    • First Affiliated Hospital of Xinjiang Medical University
  • Xinjiang, China
    • Urumqi Maternal and Child Health Care Hospital
  • Zhengzhou, China
    • The First Affiliated Hospital of Zhengzhou University
  • Guangdong
    • Guangzhou, Guangdong, China, 510150
      • Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age of 18 years or older
• 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:

• Known hypersensitivity to tranexamic acid or concentrated hydrochloric acid
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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
Placebo Comparator: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of PPH	defined by a calculated estimated blood loss > 1000 mL [Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)] or red blood cell (RBC) transfusion before day 2 postpartum .	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean total calculated blood loss	Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)] or red blood cell (RBC) transfusion before day 2 postpartum	Day 2
mean gravimetrically estimated blood loss	estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction container	postpartum 24 hours
Number of Participants with additional uterotonic agents treatment	additional uterotonic agents include oxytocin, carbetocin, carboprost, misoprostol, ergonovine et al	baseline
incidence of postpartum transfusion	include RBC, plasma, platelet, cryo et al	baseline
incidence of postpartum iron perfusion		baseline
incidence of hypovolemic shock related to PPH		baseline
incidence of interventional therapy	include arterial embolization, abdominal aortic balloon, internal iliac artery/common iliac artery balloon et al	baseline
incidence of transfer to intensive care unit		baseline
Number of Participants with additional operations performed outside cesarean section	Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al	baseline
incidence of maternal death from any cause		week 6
incidence of hospital readmission		baseline
mean peripartum change in hemoglobin	the difference between the hemoglobin levels before delivery and at D2	Day 2
mean peripartum change in hematocrit levels	the difference between the hematocrit levels before delivery and at D2	Day 2
incidence of infectious complications	include endometritis, surgical-site infection, or pelvic abscess within 6 weeks post partum	week 6
incidence of maternal thromboembolic events	including venous, arterial, or ischemic stroke or myocardial infarction within 6 weeks post partum	week 6

Collaborators and Investigators

• Sponsor: Guangzhou Medical University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Tongji Hospital; The First Affiliated Hospital of Zhengzhou University; Dongguan People's Hospital; Peking Union Medical College; Second Affiliated Hospital of Guangzhou Medical University; First Affiliated Hospital of Xinjiang Medical University; Tianjin Central Hospital of Gynecology Obstetrics; Hunan Provincial Maternal and Child Health Care Hospital; Huadu District People's Hospital of Guangzhou; Shenzhen Maternity & Child Healthcare Hospital; Northwest Women's and Children's Hospital, Xi'an, Shaanxi; Fifth Affiliated Hospital of Guangzhou Medical University; Zhuhai Women and Children's Hospital; BoAi Hospital of Zhongshan; Dalian women and children's medical group; Nanfang Hospital, Southern Medical University; Women and Children's Hospital of Chongqing Medical University; Dongguan Maternal and Child Health Care Hospital; Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan; Urumqi Maternal and Child Health Care Hospital; Shenzhen Baoan Women's and Children's Hospital; Shijiazhuang Obstetrics and Gynecology Hospital; Foshan Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): March 23, 2025

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases; Puerperal Disorders; Uterine Hemorrhage; Postpartum Hemorrhage; Hemorrhage; Placenta Previa; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: MR-44-23-016012（TRAPP）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No