Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage
Launched by RENJI HOSPITAL · Dec 22, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a medication called tranexamic acid (TXA) to help prevent a serious condition known as postpartum hemorrhage (PPH) in women who have certain autoimmune diseases. Postpartum hemorrhage is when a woman loses a lot of blood after giving birth, especially after a cesarean delivery (C-section). This trial specifically focuses on women with systemic autoimmune diseases, like lupus or rheumatoid arthritis, as they are at higher risk for PPH. The goal is to see if TXA can safely reduce blood loss and improve outcomes for both mothers and their babies.
To be eligible for this study, participants must be female, planning to have a C-section, and diagnosed with a systemic autoimmune disease. They must also agree to participate by signing an informed consent form. Women with certain health issues, like severe kidney problems or a history of blood clots, will not be able to join the trial. Participants can expect to receive TXA during their C-section and will be monitored for any side effects and overall health during recovery. This research aims to provide valuable information that could help improve care for pregnant women with autoimmune conditions in the future.
Gender
FEMALE
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
About Renji Hospital
Renji Hospital, a prestigious medical institution affiliated with Shanghai Jiao Tong University School of Medicine, is dedicated to advancing healthcare through innovative clinical research. With a strong emphasis on patient-centered care, Renji Hospital conducts a wide range of clinical trials across various therapeutic areas, harnessing cutting-edge technology and evidence-based practices. The hospital's multidisciplinary team of experienced researchers and medical professionals collaborates closely to ensure rigorous study design and execution, aiming to contribute significantly to medical knowledge and improve treatment outcomes for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Trial Officials
Jie Xiao, PHD
Study Director
Renji Hospital, Shanghai Jiaotong University, School of Medcine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported