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Recruiting Phase 4 NCT06754371

Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

Trial Parameters

Condition Postpartum Hemorrhage
Sponsor RenJi Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 276
Sex FEMALE
Min Age 18 Years
Max Age 50 Years
Start Date 2025-01-06
Completion 2027-01
Interventions
tranexamic acidnormal saline

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Patients undergoing cesarean delivery 2. Preoperative diagnosis of pregnancy with systemic autoimmune diseases (systemic lupus erythematosus, antiphospholipid syndrome, systemic sclerosis, Sjogren's syndrome, rheumatoid arthritis, undifferentiated connective tissue disease) 3. Obtain informed consent. Exclusion Criteria: 1. intrauterine fetal death 2. Existing/previous history of thromboembolism 3. Hemorrhagic disease, significant prenatal bleeding 4. Balloon placement of internal iliac artery 5. Allergic to tranexamic acid 6. Severe renal insufficiency (serum creatinine \>451μmol/L or blood urea nitrogen \>20mmol/L) 7. Epilepsy

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