RecruitingPhase 4NCT06754371

Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

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


Sponsor

RenJi Hospital

Enrollment

276 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

  • Patients undergoing cesarean delivery
  • Preoperative diagnosis of pregnancy with systemic autoimmune diseases (systemic lupus erythematosus, antiphospholipid syndrome, systemic sclerosis, Sjogren's syndrome, rheumatoid arthritis, undifferentiated connective tissue disease)
  • Obtain informed consent.

Exclusion Criteria7

  • intrauterine fetal death
  • Existing/previous history of thromboembolism
  • Hemorrhagic disease, significant prenatal bleeding
  • Balloon placement of internal iliac artery
  • Allergic to tranexamic acid
  • Severe renal insufficiency (serum creatinine \>451μmol/L or blood urea nitrogen \>20mmol/L)
  • Epilepsy

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Interventions

DRUGtranexamic acid

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

DRUGnormal 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

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NCT06754371


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