Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

NCT06754371 | Recruiting Phase 4 DMC

• 1 other identifier: LY2024-172-B
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage; Systemic Autoimmune Diseases

Keywords

postpartum hemorrhage; systemic autoimmune disease; cesarean delivery; thromboembolism

Outcome Measures

Primary Outcomes (2)

• 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.

  From skin incision to 1day after surgery

• 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;

  From skin incision to 1day after surgery

Secondary Outcomes (7)

• The volume of blood transfusion within 3days after surgery and complications

  From skin incision to 3days after surgery

• Whether additional uterotonics are needed

  From the delivery of placenta until 3 days postoperatively

• Whether other surgical intervention for PPH are needed

  From the delivery of placenta until 3 days postoperatively

• Incidence of thromboembolic events

  Patients will be followed up to one week after surgery

• Maternal complications

  Patients will be followed up to 3days after surgery

Study Arms (2)

Tranexamic acid group

EXPERIMENTAL

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

Drug: tranexamic acid

Placebo group

PLACEBO COMPARATOR

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

Drug: normal saline

Interventions

tranexamic acid DRUG

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

Also known as: TXA

Tranexamic acid group

normal saline DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• intrauterine fetal death
• Existing/previous history of thromboembolism
• Hemorrhagic disease, significant prenatal bleeding
• Balloon placement of internal iliac artery
• Allergic to tranexamic acid
• Severe renal insufficiency (serum creatinine \>451μmol/L or blood urea nitrogen \>20mmol/L)
• Epilepsy

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University, School of Medcine

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage; Thromboembolism

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jie Xiao, PHD

  Renji Hospital, Shanghai Jiaotong University, School of Medcine

  STUDY DIRECTOR

Central Study Contacts

Jie Xiao, PHD

CONTACT

+13817931390; applexiaomz@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 31, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)