NCT05811676

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,732 (actual)
• Sponsor: Guangzhou Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2023-07-12
• Primary completion: 2025-02-11
• Completion: 2025-03-23
• First posted: 2023-04-13
• Last updated: 2025-03-27

Locations

27 sites across 1 country: China