Using tranexamic acid to prevent postpartum hemorrhage in women with autoimmune diseases
Safety and Efficacy of Prophylactic Tranexamic Acid in Reducing Postpartum Hemorrhage After Cesarean Delivery in Women with Systemic Autoimmune Disease：A Randomized Controlled Trial
This study is testing if tranexamic acid can help prevent heavy bleeding after childbirth in women with autoimmune diseases who are having a cesarean delivery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06754371 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women undergoing cesarean delivery with a preoperative diagnosis of systemic autoimmune diseases.
Not a fit: Patients with a history of thromboembolism or severe renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postpartum hemorrhage and related complications in high-risk women.
How similar studies have performed: Previous studies have shown that the use of tranexamic acid can effectively reduce blood loss in low-risk populations, but this approach in high-risk autoimmune patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.