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

NCT04304625 | Recruiting Phase 3 DMC

• 1 other identifier: CHUBX 2018/64
• Study Type: interventional
• Target: 1,380
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhage; tranexamix acid; placenta previa

Outcome Measures

Primary Outcomes (1)

• Incidence of red blood cell transfusion (binary outcome) between delivery of child and discharge from postpartum hospital stay.

  Incidence of red blood cell transfusion (binary outcome) between delivery of child and discharge from postpartum hospital stay.

  baseline

Secondary Outcomes (20)

• gravimetrically estimated blood loss

  Baseline

• Occurrence of calculated blood loss > 1000ml.

  Baseline

• Occurrence of calculated blood loss > 1500ml.

  Baseline

• mean calculated blood loss

  Baseline

• linically significant PPH

  Baseline

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

After the routine prophylactic IV or IM injection of the uterotonic used in the hospital protocol's -either oxytocin or carbetocin - (as recommended by the 2014 guidelines for prevention and management of postpartum hemorrhage from the CNGOF), the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the patient within 3 minutes after birth, slowly (over 30-60 seconds), once the cord has been clamped

Drug: Tranexamic Acid / Sodium chloride

Placebo

PLACEBO COMPARATOR

After the routine prophylactic IV or IM injection of the uterotonic used in the hospital protocol's -either oxytocin or carbetocin - (as recommended by the 2014 guidelines for prevention and management of postpartum hemorrhage from the CNGOF), the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the patient within 3 minutes after birth, slowly (over 30-60 seconds), once the cord has been clamped

Drug: Tranexamic Acid / Sodium chloride

Interventions

Tranexamic Acid / Sodium chloride DRUG

After the routine prophylactic IV or IM injection of the uterotonic used in the hospital protocol's -either oxytocin or carbetocin - (as recommended by the 2014 guidelines for prevention and management of postpartum hemorrhage from the CNGOF), the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the patient within 3 minutes after birth, slowly (over 30-60 seconds), once the cord has been clamped

Placebo; Tranexamic acid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥ 18 years
• Placenta previa defined by a placental edge below 20mm from internal cervical os diagnosed at the most recent transvaginal ultrasound examination before delivery, as per 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

You may not qualify if:

• 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 renal disease (including chronic or acute kidney failure with glomerular filtration rate \<90 mL/min, renal transplantation), chronic active or acute liver disorder with hemorrhagic 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 or heterozygous; Activated protein C (APC) resistance, Protein C deficiency, Protein S deficiency - aside from pregnancy, Homocysteinemia, , Factor 2 mutation - homo or heterozygous, Deficiency in antithrombin 3), prohemorragic (von Willebrand disease requiring 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 the obstetrician in charge
• Placenta praevia diagnosed during delivery
• Abruptio placentae
• Significant bleeding (estimated blood loss\>500ml) within 12 hours before cesarean delivery
• Eclampsia / HELLP syndrome
• In utero fetal death
• Administration of low-molecular-weight heparin or antiplatelet agents during the 7 days before delivery
• Tranexamic acid contraindication
• Sodium chloride contraindication

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

RECRUITING

Related Publications (2)

• Sentilhes L, Madar H, Ifrah A, Chretien JM, Deneux-Tharaux C; TRAAPREVIA Study Group, the Groupe de Recherche en Obstetrique et Gynecologie (GROG). Study protocol. TRAAPREVIA-TRAnexamic acid for preventing blood loss following a cesarean delivery in women with a placenta pREVIA or low-lying placenta: a multicenter randomized, double blind, placebo controlled trial. BMC Pregnancy Childbirth. 2025 May 30;25(1):635. doi: 10.1186/s12884-025-07682-1.

  PMID: 40448004 DERIVED

• Larson NJ, Mergoum AM, Dries DJ, Cook A, Blondeau B, Rogers FB. THE ROLE OF TRANEXAMIC ACID IN POSTPARTUM HEMORRHAGE: A NARRATIVE REVIEW. Shock. 2024 Nov 1;62(5):620-627. doi: 10.1097/SHK.0000000000002455. Epub 2024 Aug 20.

  PMID: 39162220 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage; Placenta Previa

Interventions

Tranexamic Acid; Sodium Chloride

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; Placenta Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Loic Sentilhes, MD, PhD

CONTACT

+335 56 79 55 79; loic.sentilhes@chu-bordeaux.fr

Aurélie Darmaillacq

CONTACT

aurelie.darmaillacq@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinding is performed according to current Good Manufacturing Practices (BPF). The packaging and labelling of the experimental drugs are carried out by the PUI of CHU Angers, in accordance with the regulation of the clinical trials in force. PUI of CHU Angers will produce batches of vials (tranexamic acid or placebo according to randomization) according to the model: * TXA: 1g - 10ml * Placebo: NaCl 0.9% - 10mL
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter double-blind randomized controlled trial

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: August 7, 2020
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)