About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients undergoing cesarean delivery
Preoperative diagnosis of pregnancy with systemic autoimmune diseases (systemic lupus erythematosus, antiphospholipid syndrome, systemic sclerosis, Sjogren's syndrome, rheumatoid arthritis, undifferentiated connective tissue disease)
Obtain informed consent.
Disqualifiers
intrauterine fetal death
Existing/previous history of thromboembolism
Hemorrhagic disease, significant prenatal bleeding
Balloon placement of internal iliac artery
Trial design
Parallel
Treatments tested in this trial
tranexamic acid
Drugintravenous infusion of tranexamic acid 1g (20ml) 10min before skin dissection
normal saline
Drugintravenous infusion of normal saline 20ml 10min before skin dissection
Treatment groups
Trial outcomes
Primary outcomes
The incidence of postpartum hemorrhage
Postpartum 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 surgery
Estimated 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 outcomes
The volume of blood transfusion within 3days after surgery and complications
The volume of blood transfusion within 3days after surgery and complications(such as fever, allergy, hemolysis, renal dysfunction,etc)
Whether additional uterotonics are needed
Uterotonics other than intraoperative routine dose intravenous and intrauterine infusion of oxytocin.
Whether other surgical intervention for PPH are needed
Patients who need other surgical intervention(such as intrauterine balloon compression hemostasis, uterine artery ligation or embolization and hysterectomy) to control PPH
Incidence of thromboembolic events
The occurrence of thromboembolic events within one week of delivery, including deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke
Sponsors and contacts
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