Using tranexamic acid to prevent postpartum hemorrhage in women with autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of tranexamic acid (TXA) in preventing postpartum hemorrhage (PPH) in women undergoing cesarean delivery who have systemic autoimmune diseases. The study aims to address the high incidence of PPH in this high-risk population, particularly those with conditions like systemic lupus erythematosus. Participants will receive either TXA or normal saline, and the outcomes will be measured in terms of blood loss, need for blood transfusions, and maternal complications. The trial seeks to provide evidence for the preventive use of TXA in a demographic that has been underrepresented in previous studies.

Why it matters

Who can join: the full rules

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

Where it's running

• Renji Hospital, Shanghai Jiaotong University, School of Medcine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jie Xiao, PHD
• Email: applexiaomz@163.com
• Phone: +13817931390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.