TRAnexamic Acid for Preventing postpartum hemorrhage following a Cesarean Delivery in women with placenta praevia

TRAnexamic Acid for Preventing blood loss following a cesarean delivery in women with placenta pREVIA: a multicenter randomised, double blind placebo controlled trial (TRAAPrevia) - TRAAPrevia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004439-22-FR

Enrollment

1380

Registered

2020-01-13

Start date

2020-03-12

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum hemorrhage, placenta previa, prevention, blood loss, transfusion MedDRA version: 20.1 Level: PT Classification code 10036417 Term: Postpartum haemorrhage System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions MedDRA version: 20.0 Level: SOC Classification code 10036585 Term: Pregnancy, puerperium and perinatal conditions System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Product Name: exacyl 1g-10mL Pharmaceutical Form: Solution for injection CAS Number: 1197-18-8 Current Sponsor code: TRANEXAMIC ACID Other descriptive name: TRANEXAMIC ACID Concentration unit: ml mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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 [2, 46]. • Cesarean delivery before or during labor • Gestational age at delivery = 32 weeks + 0 • Affiliated or beneficiary to a health security system • Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1380 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 renal disease (including chronic or acute kidney failure with glomerular filtration rate 3N, 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 such as von Willebrand disease requiring desmopressin treatment during delivery, Thrombocytopenia ( 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 • Hypersensitivity to tranexamic acid or sodium chloride • Poor understanding of the French language

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of a low dose of TXA (1g) administered within 3 minutes after delivery of the child in addition to prophylactic uterotonic in women with placenta previa and cesarean delivery, versus placebo, on the incidence of red blood cell (RBC) transfusion between delivery of child and discharge from postpartum hospital stay;Secondary Objective: To compare the effect of a low dose of TXA (1g) after cesarean delivery in women with placenta previa, versus placebo, on other markers of postpartum blood loss on • estimated blood loss (estimated and calculated) • mean shock index measured at 15, 30, 45, 60 and 120 minutes after birth, or if PPH occur • proportion of women requiring supplementary uterotonic treatment, iron sucrose perfusion until discharge, red blood cell units transfused • incidence of arterial embolisation or emergency surgery for PPH • incidence of maternal postpartum transfer to a higher level of care • proportion of breastfeeding at hospital discharge • maternal death for any cause • nausea, vomiting, phosphenes, dizziness • thromboembolic events and other severe unexpected adverse reactions • transfer to neonatal ICU, hospitalisation within 12 weeks after birth • women’s satisfaction and psychological status;Primary end point(s): The primary outcome of the trial is the incidence of red blood cell transfusion between delivery of child and discharge from postpartum hospital stay. We chose this primary outcome for the following reasons: Assessment of postpartum blood loss is difficult in the context of cesarean delivery, and its accuracy has been questioned, whatever the method used. Moreover, RBC transfusion is considered as a significant maternal morbidity equivalent of blood loss equal or superior to 1,000 mL and it is rare that a patient received RBC transfusion for a blood loss less than 1,000 ml. As such, it is included in the recently published core set outcomes recommended for studies evaluating interventions for PP	—

Measure

Time frame

Main Objective: To compare the effect of a low dose of TXA (1g) administered within 3 minutes after delivery of the child in addition to prophylactic uterotonic in women with placenta previa and cesarean delivery, versus placebo, on the incidence of red blood cell (RBC) transfusion between delivery of child and discharge from postpartum hospital stay;Secondary Objective: To compare the effect of a low dose of TXA (1g) after cesarean delivery in women with placenta previa, versus placebo, on other markers of postpartum blood loss on • estimated blood loss (estimated and calculated) • mean shock index measured at 15, 30, 45, 60 and 120 minutes after birth, or if PPH occur • proportion of women requiring supplementary uterotonic treatment, iron sucrose perfusion until discharge, red blood cell units transfused • incidence of arterial embolisation or emergency surgery for PPH • incidence of maternal postpartum transfer to a higher level of care • proportion of breastfeeding at hospital discharge • maternal death for any cause • nausea, vomiting, phosphenes, dizziness • thromboembolic events and other severe unexpected adverse reactions • transfer to neonatal ICU, hospitalisation within 12 weeks after birth • women’s satisfaction and psychological status;Primary end point(s): The primary outcome of the trial is the incidence of red blood cell transfusion between delivery of child and discharge from postpartum hospital stay. We chose this primary outcome for the following reasons: Assessment of postpartum blood loss is difficult in the context of cesarean delivery, and its accuracy has been questioned, whatever the method used. Moreover, RBC transfusion is considered as a significant maternal morbidity equivalent of blood loss equal or superior to 1,000 mL and it is rare that a patient received RBC transfusion for a blood loss less than 1,000 ml. As such, it is included in the recently published core set outcomes recommended for studies evaluating interventions for PP

—

Secondary

Measure	Time frame
Secondary end point(s): • Relative to postpartum blood loss - gravimetrically estimated and calculated blood loss, - calculated blood loss > 1500 ml and > 1000 mL. - provider-assessed clinically significant PPH - shock index, defined by the ratio of heart rate to systolic blood pressure, measured at 15, 30, 45, 60 and 120 minutes after birth, or if PPH occurs - supplementary uterotonic treatment - iron sucrose perfusion until discharge - number of red blood cell units transfused between delivery of child and discharge from postpartum hospital stay. - arterial embolisation or emergency surgery for PPH - maternal postpartum transfer to a higher level of care - breastfeeding at hospital discharge - maternal death for any cause - Hb within 7 days before delivery and at day 2 postpartum - Ht within 7 days before delivery and at day 2 postpartum • Relative to potential adverse reactions: - Occurrence of nausea, vomiting, phosphenes, dizziness ; these events will be collected up to hospital discharge); - Occurrence of thromboembolic events ; these events will be assessed up to 12 weeks after the delivery • Occurrence of neonatal outcomes: transfer to neonatal ICU. • Women’s satisfaction and psychological status: - self-administered questionnaire at day 2 postpartum - self-administered questionnaire at 8 weeks of postpartum, - questionnaire at 12 weeks of postpartum;Timepoint(s) of evaluation of this end point: Baseline, day 2, 8 and 12 week postpartum	—

Measure

Time frame

Secondary end point(s): • Relative to postpartum blood loss - gravimetrically estimated and calculated blood loss, - calculated blood loss > 1500 ml and > 1000 mL. - provider-assessed clinically significant PPH - shock index, defined by the ratio of heart rate to systolic blood pressure, measured at 15, 30, 45, 60 and 120 minutes after birth, or if PPH occurs - supplementary uterotonic treatment - iron sucrose perfusion until discharge - number of red blood cell units transfused between delivery of child and discharge from postpartum hospital stay. - arterial embolisation or emergency surgery for PPH - maternal postpartum transfer to a higher level of care - breastfeeding at hospital discharge - maternal death for any cause - Hb within 7 days before delivery and at day 2 postpartum - Ht within 7 days before delivery and at day 2 postpartum • Relative to potential adverse reactions: - Occurrence of nausea, vomiting, phosphenes, dizziness ; these events will be collected up to hospital discharge); - Occurrence of thromboembolic events ; these events will be assessed up to 12 weeks after the delivery • Occurrence of neonatal outcomes: transfer to neonatal ICU. • Women’s satisfaction and psychological status: - self-administered questionnaire at day 2 postpartum - self-administered questionnaire at 8 weeks of postpartum, - questionnaire at 12 weeks of postpartum;Timepoint(s) of evaluation of this end point: Baseline, day 2, 8 and 12 week postpartum

—

Countries

France

Contacts

Public ContactSophie Regueme

CHU de Bordeaux

sophie.regueme@chu-bordeaux.fr33557821067

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026