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Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

Safety and Efficacy of Prophylactic Tranexamic Acid in Reducing Postpartum Hemorrhage After Cesarean Delivery in Women with Systemic Autoimmune Disease:A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06754371
Enrollment
276
Registered
2024-12-31
Start date
2025-01-06
Completion date
2027-06-30
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage, Systemic Autoimmune Diseases

Keywords

postpartum hemorrhage, systemic autoimmune disease, cesarean delivery, thromboembolism

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.

Detailed description

The worldwide estimated cumulative prevalence of autoimmune disease is approximately 5%. Studies are often limited by small sample sizes and focused on a specific autoimmune disease such as systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS), which is characterized by the production of autoantibodies leading to inflammation of multiple organs. Systemic autoimmune diseases are associated with adverse pregnancy outcomes (APOs), including increased cesarean delivery rates, PPH, preeclampsia, thromboembolism, abortion, premature delivery, and intrauterine growth restriction. Preeclampsia is the most commonly reported complication in patients with SLE and is also a high risk factor for PPH. The incidence of PPH in women with SLE has been reported to be as high as 34%. PPH increases the need for blood transfusion and related complications and is a significant clinical and socio-economic problem. Therefore, prevention of PPH is the key to reduce the postpartum complications of high-risk women. At present, the methods commonly used to prevent PPH after cesarean delivery include uterine massage, prophylactic use of uterine contraction agents in the third stage of labor, and early use of TXA. Recent clinical studies of TXA use in high-risk cesarean delivery women have shown that prophylactic use of TXA significantly reduces blood loss, prevents PPH, and reduces ICU admission and length of stay. There was no evidence of an increased risk of maternal-related complications with TXA use. But there is still a lack of relevant research on TXA used in pregnant women with systemic autoimmune diseases. Anti-phospholipid antibodies (aPL) are often present in SLE and APS patients, which predict serious perinatal complications and are associated with the risk of thrombosis. aPL are detected not only in SLE and APS but also in other connective tissue diseases such as systemic sclerosis (SSc), Sjögren's syndrome (SS), rheumatoid arthritis (RA), and undifferentiated connective tissue disease (UCTD). Although TXA has been widely used in patients at high risk for thromboembolism, such as trauma, orthopedics, and cardiac surgery in recent years, the evidence strongly supports that it does not increase the risk of death or thromboembolic complications. More evidence from high quality randomized controlled trials is needed to assess the benefits and risks of its use in women at high risk of PPH after cesarean delivery. The aim of this study was to evaluate the safety and efficacy of TXA in preventing PPH after cesarean delivery in women with systemic autoimmune disease. Patients undergoing cesarean delivery were randomly assigned to TXA group(intravenous infusion of TXA 1g (20ml) 10min before skin dissection) and placebo group(intravenous infusion of normal saline 20ml 10min before skin dissection).The estimated blood loss 24h postoperatively, blood transfusion 3d postpartum, additional uterotonics, other surgical intervention for PPH and thromboembolic events were recorded.

Interventions

DRUGtranexamic acid

intravenous infusion of tranexamic acid 1g (20ml) 10min before skin dissection

DRUGnormal saline

intravenous infusion of normal saline 20ml 10min before skin dissection

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of postpartum hemorrhageFrom skin incision to 1day after surgeryPostpartum hemorrhage is defined as blood loss of 1000 mL or more within the first 24 h after cesarean delivery.
Estimated blood loss within 1day after surgeryFrom skin incision to 1day after surgeryEstimated blood loss is calculated by GROSS EQUATION: Estimated Blood Loss (EBL) = EBV ×((HCT1 - HCT2)/(HCT mean)), EBV = Estimated Blood volume; whereas EBV = Patient's weight (in kilogram) × 70 mL/kg, HCT1=preoperative hematocrit, HCT2 = postoperative hematocrit, and HCT mean = (HCT1 + HCT2)/2;

Secondary

MeasureTime frameDescription
Whether additional uterotonics are neededFrom the delivery of placenta until 3 days postoperativelyUterotonics other than intraoperative routine dose intravenous and intrauterine infusion of oxytocin.
Whether other surgical intervention for PPH are neededFrom the delivery of placenta until 3 days postoperativelyPatients who need other surgical intervention(such as intrauterine balloon compression hemostasis, uterine artery ligation or embolization and hysterectomy) to control PPH
Estimated intraoperative blood lossFrom skin incision to the end of the surgeryEstimated intraoperative blood loss is calculated using the formula: collected blood volume in the suction canister (ml)-the volume of amniotic fluid (ml)-the volume of flushing (ml) + the volume from the gauze tampon (ml)
Maternal complicationsPatients will be followed up to 3days after surgeryOccurrence of adverse effects (nausea, vomiting, headache, epilepsy, renal impairment,coagulopathy) within 3days after surgery.
Maternal and neonatal 3 months mortalityPatients and neonates will be followed up to 3 months after surgeryAll-cause 3 months mortality
Incidence of thromboembolic eventsPatients will be followed up to one week after surgeryThe occurrence of thromboembolic events within one week of delivery, including deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke
The volume of blood transfusion within 3days after surgery and complicationsFrom skin incision to 3days after surgeryThe volume of blood transfusion within 3days after surgery and complications(such as fever, allergy, hemolysis, renal dysfunction,etc)

Countries

China

Contacts

Primary ContactJie Xiao, PHD
applexiaomz@163.com+13817931390

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026