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

Guangzhou Medical University

Status and phase: Completed; Phase 3

Conditions: Placenta Previa; Hemorrhage, Postpartum

Treatments: Drug: Tranexamic acid; Other: 0.9% sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05811676

MR-44-23-016012（TRAPP）

Details and patient eligibility

About

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.

Enrollment: 1,732 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,732 participants in 2 patient groups, including a placebo group

study group

Experimental group

Description:

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

Treatment:

Drug: Tranexamic acid

control group

Placebo Comparator group

Description:

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

Treatment:

Other: 0.9% sodium chloride