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

NCT05811676 | Completed Phase 3 DMC

• 1 other identifier: MR-44-23-016012（TRAPP）
• Study Type: interventional
• Target: 1,732
• Locations: 1 country
• Sites: 27

Brief Summary

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.

Conditions

Hemorrhage, Postpartum; Placenta Previa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• mean total calculated blood loss

  Day 2

• mean gravimetrically estimated blood loss

  postpartum 24 hours

• Number of Participants with additional uterotonic agents treatment

  baseline

• incidence of postpartum transfusion

  baseline

• incidence of postpartum iron perfusion

  baseline

Study Arms (2)

study group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

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

study group

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

control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (27)

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

Guangzhou, Guangdong, 510150, China

Location

Peking Union Medical College

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

Women and Children's Hospital of Chongqing Medical University

Chongqing, China

Location

Dalian Women and Children's Medical Group

Dalian, China

Location

Dongguan Maternal and Child Health Care Hospital

Dongguan, China

Location

The Tenth Affiliated Hospital of Southern Medical University; Dongguan People's Hospital

Dongguan, China

Location

Foshan Women and Children Hospital

Foshan, China

Location

Boai Hospital of Zhongshan

Guangzhou, China

Location

Huadu District People's Hospital of Guangzhou

Guangzhou, China

Location

Nanfang Hospital, Southern Medical University, Guangzhou

Guangzhou, China

Location

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

The first Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Zhuhai Women and Children's Hospital

Guangzhou, China

Location

Obstetrics Department, the Maternal and Child Health Hospital of Hunan Province

Hunan, China

Location

Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University

Jinan, China

Location

Shenzhen Baoan Women's and Children's Hospital

Shenzhen, China

Location

Shenzhen Maternal ＆ Child Healthcare Hospital Affiliated Southern Medical University

Shenzhen, China

Location

Shijiazhuang Obstetrics and Gynecology Hospital

Shijiazhuang, China

Location

Tianjin Central Hospital of Gynecology Obsterics

Tianjin, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

Northwest Women's and Children's Hospital

Xi'an, China

Location

First Affiliated Hospital of Xinjiang Medical University

Xinjiang, China

Location

Urumqi Maternal and Child Health Care Hospital

Xinjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Related Publications (1)

• Zhang L, Hu M, Bi S, Poon LC, He F, Li H, Zhang Y, Gu Z, Wang Z, Du L, Chen D; TRAPP Study Group. TRAPP- Protocol for Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa. Matern Fetal Med. 2026 Jan;8(1):3-12. doi: 10.1097/FM9.0000000000000297. Epub 2025 Jul 15.

  PMID: 41624591 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage; Placenta Previa

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Obstetrics and Gynecology, The Third Affiliated Hospital

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 13, 2023
• Study Start: July 12, 2023
• Primary Completion: February 11, 2025
• Study Completion: March 23, 2025
• Last Updated: March 27, 2025

Record last verified: 2024-08

Locations

CN (27)