drugset / Trial / NCT05811676
Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa
Phase 3
Completed
1732 enrolled
Guangzhou Medical University
BoAi Hospital of Zhongshan · collabChildren's Hospital of Chongqing Medical University · collabDalian women and children's medical group · collabDongguan Maternal and Children Health Hospital · collabDongguan People's Hospital · collabFifth Affiliated Hospital of Guangzhou Medical University · collabFirst Affiliated Hospital of Xinjiang Medical University · collabFirst Affiliated Hospital, Sun Yat-Sen University · collabFoshan Women's and Children's Hospital · collabHuadu District People's Hospital of Guangzhou · collabHunan Provincial Maternal and Child Health Care Hospital · collabNanfang Hospital, Southern Medical University · collabNorthwest Women's and Children's Hospital, Xi'an, Shaanxi · collabPeking Union Medical College · collabSecond Affiliated Hospital of Guangzhou Medical University · collabShandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University · collabShenzhen Baoan Women's and Children's Hospital · collabShenzhen Maternity & Child Healthcare Hospital · collabShijiazhuang Obstetrics and Gynecology Hospital · collabThe First Affiliated Hospital of Zhengzhou University · collabTianjin Central Hospital of Gynecology Obstetrics · collabTongji Hospital · collabUrumqi Maternal and Child Health Care Hospital · collabZhuhai Women and Children's Hospital · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2023-07-12
- Primary completion
- 2025-02-11
- Completion
- 2025-03-23
Publications
- Zhang L, Bi S, Chen L, Du L, He F, Qiao Y, Li Z, Zeng W, Zhao X, Chen X, Li X, Ding G, Zhou W, Sun B, Guo Q, Guo X, Jin F, Wang X, Zhu Q, Sun Q, Jiang S, Wang X, Cai F, Jiang Y, Gao J, Wang Z, Wang Z, Zhang L, Liu JM, Huang L, Yu L, Chen J, Zhang S, Poon LC, Li HT, Chen D; study's collaborator group. Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial. BMJ. 2026 May 13;393:e089636. doi: 10.1136/bmj-2026-089636.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 1 g | Intravenous |