Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study 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

Primary outcome measure(s)

• The incidence of postpartum hemorrhage — From skin incision to 1day after surgery
  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 — From skin incision to 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;

Trial sites (1)

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