A Phase 3 interventional study of Tranexamic Acid / Sodium chloride in Postpartum Hemorrhage, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Treatment
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
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.
469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's planned enrollment of 1,380 is above the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Drug pages: 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
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.
Time frame: baseline
gravimetrically estimated blood loss
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)
Time frame: Baseline
Occurrence of calculated blood loss > 1000ml.
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
Time frame: Baseline
Occurrence of calculated blood loss > 1500ml.
calculated blood loss \> 1500 ml
Time frame: Baseline
mean calculated blood loss
mean calculated blood loss
Time frame: Baseline
linically significant PPH
provider-assessed clinically significant PPH
Time frame: Baseline
shock index
mean shock index defined by the ratio of heart rate to systolic blood pressure
Time frame: 15, 30, 45, 60 and 120 minutes after birth
supplementary uterotonic treatment
supplementary uterotonic treatment
Time frame: Baseline
iron sucrose perfusion
iron sucrose perfusion until discharge
Time frame: Baseline
red blood cell units transfusion
number of red blood cell units transfused between delivery of child and discharge from postpartum hospital stay.
Time frame: Baseline
number of transfusion
proportion of women transfused between delivery of child and 24 hours postpartum
Time frame: Baseline
arterial embolisation
arterial embolisation or emergency surgery for PPH
Time frame: Baseline
maternal postpartum transfer
maternal postpartum transfer to a higher level of care
Time frame: Baseline
change in peripartum Hb
mean change in peripartum Hb (difference between most recent Hb within 7 days before surgery and at day 2 postpartum).
Time frame: day 2
change in peripartum Ht
mean change in peripartum Ht (difference between most recent Ht within 7 days before surgery and at day 2 postpartum).
Time frame: day 2
proportion of breastfeeding at hospital discharge
proportion of breastfeeding at hospital discharge
Time frame: Baseline
maternal death for any cause
maternal death for any cause
Time frame: Baseline
mild adverse reactions of TXA
mild adverse reactions of TXA for women (e.g.: nausea, vomiting, phosphenes, dizziness)
Time frame: Hospitalization stay
thromboembolic events
Occurrence of thromboembolic events and other severe unexpected adverse reactions (e.g incidence of deep vein thrombosis confirmed by radiological exams, pulmonary embolism confirmed by radiological exams, myocardial infarction, seizure, renal failure necessitating dialysis)
Time frame: week 12
transfer to neonatal ICU
neonatal outcomes: transfer to neonatal ICU
Time frame: Baseline
Women's satisfaction and psychological status
Women's satisfaction and psychological status (self-administered questionnaire at day 2 postpartum and self-administered questionnaire sent by mail at 8 weeks).
Time frame: Week 8; Week 12
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2020 (actual). Primary completion is estimated for Jun 2027, 82 months after the start.
Of 20 phase 3 interventional studies under Postpartum Hemorrhage, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's planned 82 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Tranexamic Acid · Sodium Chloride
University Hospital, Bordeaux →