TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA

Last updated: February 7, 2025
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

3

Condition

Hemorrhage

Pregnancy Complications

Treatment

Tranexamic Acid / Sodium chloride

Clinical Study ID

NCT04304625
CHUBX 2018/64
  • Ages 18-65
  • Female

Study Summary

Several randomized, controlled trials, mostly involving women undergoing cesarean delivery, have shown that the prophylactic intravenous administration of 1 g of tranexamic acid after childbirth reduced blood loss. Most were small, single-centre trials with considerable methodologic limitations.

It is important to emphasize that none of these RCTs has included women at increased risk of PPH such as placenta previa, a context in which the prevalence of moderate and severe blood loss is significantly higher and where the magnitude of the effect of TXA may highly differ compared to low risk women

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age≥ 18 years

  • Placenta previa defined by a placental edge below 20mm from internal cervical osdiagnosed at the most recent transvaginal ultrasound examination before delivery, asper French guidelines

  • Cesarean delivery before or during labor

  • Gestational age at delivery ≥ 32 weeks + 0

  • Affiliated or beneficiary to a health security system

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombotic event

  • History of epilepsy or seizure

  • Chronic or acute cardiovascular disease (including foramen oval, mitral stenosis,aortic stenosis, heart transplant, pulmonary hypertension); chronic or acute renaldisease (including chronic or acute kidney failure with glomerular filtration rate <90 mL/min, renal transplantation), chronic active or acute liver disorder withhemorrhagic or thrombotic risk (including cirrhosis, portal hypertension,Budd-Chiari syndrome)

  • Active autoimmune disease with thromboembolic risk (including lupus,antiphospholipid syndrome, Crohn's disease)

  • Sickle cell disease (homozygous)

  • Severe hemostasis disorder prothrombotic (Factor V Leiden mutation - homo orheterozygous; Activated protein C (APC) resistance, Protein C deficiency, Protein Sdeficiency - aside from pregnancy, Homocysteinemia, , Factor 2 mutation - homo orheterozygous, Deficiency in antithrombin 3), prohemorragic (von Willebrand diseaserequiring desmopressin treatment during delivery, thrombocytopenia (<30000/mm3),Glanzmann disease, hypofibrinogenemia (<1g/L) -aside from pregnancy)

  • High prenatal suspicion of placenta accreta spectrum disorder according to theobstetrician in charge

  • Placenta praevia diagnosed during delivery

  • Abruptio placentae

  • Significant bleeding (estimated blood loss>500ml) within 12 hours before cesareandelivery

  • Eclampsia / HELLP syndrome

  • In utero fetal death

  • Administration of low-molecular-weight heparin or antiplatelet agents during the 7days before delivery

  • Tranexamic acid contraindication

  • Sodium chloride contraindication

  • Women under legal protection

  • Poor understanding of the French language

Study Design

Total Participants: 1380
Treatment Group(s): 1
Primary Treatment: Tranexamic Acid / Sodium chloride
Phase: 3
Study Start date:
August 07, 2020
Estimated Completion Date:
September 30, 2027

Study Description

TXA is a promising candidate drug, inexpensive and easy to administer, that can be easily added to the delivery management of women worldwide. Strong evidence that TXA reduces blood transfusion in elective and emergency surgery, outside obstetrics, has been available for many years, whatever the type of surgery (ie cardiac, orthopaedic, hepatic, urological, and vascular surgery). Tranexamic acid was recently shown to reduce bleeding-related mortality among women with postpartum hemorrhage, especially when the drug was administered shortly after delivery. A meta-analysis of data from individual patients including data from patients with trauma and women with postpartum hemorrhage suggested the importance of early treatment.

Several randomized, controlled trials (RCTs), involving women undergoing cesarean delivery, as well have meta-analyses, have shown that the prophylactic intravenous administration of 1 g of tranexamic acid after childbirth reduced blood loss. Most of them were small, single- center trials with considerable methodologic limitations. Thus, no guidelines advocate the use of tranexamic acid to prevent blood loss after cesarean delivery. Moreover, it is important to emphasize that none of these RCTs has included women at increased risk of PPH such as placenta previa, a context in which the prevalence of moderate and severe blood loss is significantly higher and where the magnitude of the effect of TXA may highly differ compared to low risk women.

The aim of our study is to conduct a large multicentre randomised, double blind placebo controlled trial to adequately assess the impact of TXA for preventing PPH following a cesarean delivery in women with placenta previa.

Connect with a study center

  • CHU Bordeaux

    Bordeaux,
    France

    Active - Recruiting

+−

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.