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

• Status: Not yet recruiting
• Trial end date: 2025-11-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Guangzhou Medical University
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Age 18-55 years old with a singleton

• 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

• Planned cesarean delivery

• Signed informed consent

Exclusion Criteria:

• Known hypersensitivity to tranexamic acid or 0.95% sodium chloride

• History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, or stroke) thrombosis

• History of epilepsy or seizure

• Any known active cardiovascular, renal, or liver disorders

• Autoimmune disease

• Sickle cell disease

• Severe hemorrhagic disease

• Administration of low-molecular-weight heparin or antiplatelet agents in the week before delivery

• Severe thrombin dysfunction, or prothrombin time and/or activated partial thrombin time exceeding the upper limit of normal, or platelet count < 80*10^9/L

• placental abruption

• In-utero fetal death

• Failed vaginal birth

• Planned general anesthesia

• gestational hypertension disease or HELLP syndrome

• Acquired color vision deficiency

• Significant bleeding (estimated blood loss>500ml) within 12 hours before cesarean delivery

• multiple pregnancies

• Participated in other clinical studies within 3 months prior to inclusion

• Intraoperative placenta retention in situ or direct uterine subtotal/total excision without attempting to expulsion the placenta