Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Postpartum Hemorrhage, Systemic Autoimmune Diseases

In brief

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.

Key facts

Study ID

NCT06754371

Run by

RenJi Hospital

People needed

276

Starts

2025-01-06

Expected to finish

2027-06-01

Last updated by the study team

2025-03-17

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Renji Hospital, Shanghai Jiaotong University, School of Medcine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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