Actively Recruiting
Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage
Led by RenJi Hospital · Updated on 2025-03-17
276
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing cesarean delivery
- Diagnosed with systemic autoimmune diseases such as systemic lupus erythematosus, antiphospholipid syndrome, systemic sclerosis, Sjogren's syndrome, rheumatoid arthritis, or undifferentiated connective tissue disease
- Provided informed consent to participate
You will not qualify if you...
- Intrauterine fetal death
- History of thromboembolism
- Bleeding disorders or significant prenatal bleeding
- Use of balloon placement in internal iliac artery
- Allergy to tranexamic acid
- Severe kidney failure (serum creatinine greater than 451 µmol/L or blood urea nitrogen greater than 20 mmol/L)
- Epilepsy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Renji Hospital, Shanghai Jiaotong University, School of Medcine
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Jie Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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