Current partner codePEPTIDESDE
NCT04304625·Phase 3·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 3

Enrollment

1,380

Locations

1

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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

Full detailed 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.

Interventions

Treatment arms and agents.

DRUG

Tranexamic Acid / Sodium chloride

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

Timeline

From registration to results.

  1. First posted

    Mar 11, 2020

  2. Study start

    Aug 7, 2020

  3. Primary completion

    Jun 2027

  4. Study completion

    Sep 2027

  5. Results posted

    Not reported

  6. Registry updated

    Feb 10, 2025

Outcomes

What the study measures.

Primary outcomes

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

Time frame · baseline

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

Secondary outcomes

gravimetrically estimated blood loss

Time frame · Baseline

gravimetrically estimated blood loss by measuring the suction volume and swab weight (estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/1.05 + volume included in the suction container)

Occurrence of calculated blood loss > 1000ml.

Time frame · Baseline

Calculated blood loss = estimated blood volume × (preoperative Ht - postoperative Ht)/preoperative Ht (where estimated blood volume = weight (kg) × 85). Preoperative Ht will be the most recent Ht within 7 days before delivery. Postoperative Ht will be measured at day 2 postpartum

Occurrence of calculated blood loss > 1500ml.

Time frame · Baseline

calculated blood loss \> 1500 ml

mean calculated blood loss

Time frame · Baseline

mean calculated blood loss

linically significant PPH

Time frame · Baseline

provider-assessed clinically significant PPH

shock index

Time frame · 15, 30, 45, 60 and 120 minutes after birth

mean shock index defined by the ratio of heart rate to systolic blood pressure

supplementary uterotonic treatment

Time frame · Baseline

supplementary uterotonic treatment

iron sucrose perfusion

Time frame · Baseline

iron sucrose perfusion until discharge

red blood cell units transfusion

Time frame · Baseline

number of red blood cell units transfused between delivery of child and discharge from postpartum hospital stay.

number of transfusion

Time frame · Baseline

proportion of women transfused between delivery of child and 24 hours postpartum

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
FEMALE
Healthy volunteers
No

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 * 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 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 \<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 * Women under legal protection * Poor understanding of the French language

Study locations

1 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

CHU Bordeaux

Bordeaux, France

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

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