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RECRUITING
NCT06754371
PHASE4

Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

Summary

Postpartum hemorrhage (PPH) is the most significant leading cause of pregnancy-related mortality in high-risk cesarean delivery women. Systemic autoimmune diseases are associated with adverse pregnancy outcomes (APOs), including PPH, preeclampsia, thromboembolism, abortion, and intrauterine growth restriction. The incidence of PPH in women with systemic lupus erythematosus has been reported to be as high as 34%. Prevention of PPH is the key to reduce complications in high-risk women. In recent years, a large number of clinical studies have confirmed that the early preventive use of tranexamic acid(TXA) can reduce the amount of blood loss, the need for additional uterine contraction agents, the risk of blood transfusion, and maternal adverse outcomes, and do not increase the risk of thromboembolic events, which can be used to prevent PPH. However, the study population of TXA is mainly low-risk puerpera, and there is still a lack of relevant research on TXA used in pregnant women with systemic autoimmune diseases. The purpose of this study was to evaluate the safety and efficacy of TXA in preventing postpartum hemorrhage after cesarean delivery in women with systemic autoimmune disease, as well as the maternal and neonatal risks associated with systemic autoimmune disease, to provide evidence for clinical practice and further research.

Official title: Safety and Efficacy of Prophylactic Tranexamic Acid in Reducing Postpartum Hemorrhage After Cesarean Delivery in Women with Systemic Autoimmune Disease:A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2025-01-06

Completion Date

2027-06

Last Updated

2025-03-17

Healthy Volunteers

No

Interventions

DRUG

tranexamic acid

intravenous infusion of tranexamic acid 1g (20ml) 10min before skin dissection

DRUG

normal saline

intravenous infusion of normal saline 20ml 10min before skin dissection

Locations (1)

Renji Hospital, Shanghai Jiaotong University, School of Medcine

Shanghai, Shanghai Municipality, China