Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorRenJi Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • tranexamic acid

    Drug

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

  • normal saline

    Drug

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

Treatment groups

276 Participants
are divided into 2 treatment groups
Group A: Tranexamic acid groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From skin incision to 1day after surgery
2

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;

Time frame
From skin incision to 1day after surgery

Secondary outcomes

1

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)

Time frame
From skin incision to 3days after surgery
2

Whether additional uterotonics are needed

Uterotonics other than intraoperative routine dose intravenous and intrauterine infusion of oxytocin.

Time frame
From the delivery of placenta until 3 days postoperatively
3

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

Time frame
From the delivery of placenta until 3 days postoperatively
4

Incidence of thromboembolic events

The occurrence of thromboembolic events within one week of delivery, including deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke

Time frame
Patients will be followed up to one week after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.