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Completed

NCT Number: NCT05811676

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

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.

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Key information

Conditions

Hemorrhage, Postpartum Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Placenta Diseases Placenta Previa Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

Other

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

Primary outcomes

  1. Incidence of PPH

    Time frame: Day 2

    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 .

Secondary outcomes

  1. mean total calculated blood loss

    Time frame: Day 2

    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

  2. mean gravimetrically estimated blood loss

    Time frame: postpartum 24 hours

    estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction container

  3. Number of Participants with additional uterotonic agents treatment

    Time frame: baseline

    additional uterotonic agents include oxytocin, carbetocin, carboprost, misoprostol, ergonovine et al

  4. incidence of postpartum transfusion

    Time frame: baseline

    include RBC, plasma, platelet, cryo et al

  5. incidence of postpartum iron perfusion

    Time frame: baseline

  6. incidence of hypovolemic shock related to PPH

    Time frame: baseline

  7. incidence of interventional therapy

    Time frame: baseline

    include arterial embolization, abdominal aortic balloon, internal iliac artery/common iliac artery balloon et al

  8. incidence of transfer to intensive care unit

    Time frame: baseline

  9. Number of Participants with additional operations performed outside cesarean section

    Time frame: baseline

    Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al

  10. incidence of maternal death from any cause

    Time frame: week 6

  11. incidence of hospital readmission

    Time frame: baseline

  12. mean peripartum change in hemoglobin

    Time frame: Day 2

    the difference between the hemoglobin levels before delivery and at D2

  13. mean peripartum change in hematocrit levels

    Time frame: Day 2

    the difference between the hematocrit levels before delivery and at D2

  14. incidence of infectious complications

    Time frame: week 6

    include endometritis, surgical-site infection, or pelvic abscess within 6 weeks post partum

  15. incidence of maternal thromboembolic events

    Time frame: week 6

    including venous, arterial, or ischemic stroke or myocardial infarction within 6 weeks post partum

Sponsors and collaborators

Lead sponsor

Guangzhou Medical University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TRAPP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2023
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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