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Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

NCT06754371 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2025-03-17

No results posted yet for this 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.

Conditions

  • Postpartum Hemorrhage
  • Systemic Autoimmune Diseases

Interventions

DRUG

tranexamic acid

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

DRUG

normal saline

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

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Jie Xiao, PHD · Renji Hospital, Shanghai Jiaotong University, School of Medcine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2027-01-31
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06754371 on ClinicalTrials.gov