NCT06754371 Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage
| NCT ID | NCT06754371 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | RenJi Hospital |
| Condition | Postpartum Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 276 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 276 participants in total. It began in 2025-01-06 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jie Xiao, PHD
STUDY DIRECTOR
Renji Hospital, Shanghai Jiaotong University, School of Medcine
Frequently Asked Questions
Who can join the NCT06754371 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Postpartum Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06754371 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06754371 currently recruiting?
Yes, NCT06754371 is actively recruiting participants. Contact the research team at applexiaomz@163.com for enrollment information.
Where is the NCT06754371 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06754371 clinical trial?
NCT06754371 is sponsored by RenJi Hospital. The principal investigator is Jie Xiao, PHD at Renji Hospital, Shanghai Jiaotong University, School of Medcine. The trial plans to enroll 276 participants.