Actively Recruiting

Phase 4
Age: 18Years - 50Years
FEMALE
NCT06754371

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

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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