Postpartum HemorrhagePhase 3TRAAPreviaNCT04304625
TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA
A Phase 3 study testing Tranexamic Acid / Sodium chloride in people with Postpartum Hemorrhage, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Tranexamic Acid / Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,380 participants
- Where
- 1 siteFrance
- Study dates
- 7 Aug 2020to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aurélie Darmaillacq contact
France1 site, 1 recruiting
- Recruiting
CHU Bordeaux
Bordeaux
Loic Sentilhes Sentilhes, MD, PhD, loic.sentilhes@chu-bordeaux.fr
About this study
Official title: TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA: a Multicenter Randomised, Double Blind Placebo Controlled Trial
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
Read the 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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Tranexamic Acid / Sodium chloride
- Keywords
- Postpartum hemorrhage, tranexamix acid, placenta previa
- Medical subject headings
- Postpartum Hemorrhage, Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid / Sodium chlorideDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Tranexamic Acid / Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (20)
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)
Measured: 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
Measured: Baseline
Occurrence of calculated blood loss > 1500ml.
calculated blood loss > 1500 ml
Measured: Baseline
mean calculated blood loss
mean calculated blood loss
Measured: Baseline
linically significant PPH
provider-assessed clinically significant PPH
Measured: Baseline
shock index
mean shock index defined by the ratio of heart rate to systolic blood pressure
Measured: 15, 30, 45, 60 and 120 minutes after birth
supplementary uterotonic treatment
supplementary uterotonic treatment
Measured: Baseline
iron sucrose perfusion
iron sucrose perfusion until discharge
Measured: Baseline
red blood cell units transfusion
number of red blood cell units transfused between delivery of child and discharge from postpartum hospital stay.
Measured: Baseline
number of transfusion
proportion of women transfused between delivery of child and 24 hours postpartum
Measured: Baseline
arterial embolisation
arterial embolisation or emergency surgery for PPH
Measured: Baseline
maternal postpartum transfer
maternal postpartum transfer to a higher level of care
Measured: 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).
Measured: 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).
Measured: day 2
proportion of breastfeeding at hospital discharge
proportion of breastfeeding at hospital discharge
Measured: Baseline
maternal death for any cause
maternal death for any cause
Measured: Baseline
mild adverse reactions of TXA
mild adverse reactions of TXA for women (e.g.: nausea, vomiting, phosphenes, dizziness)
Measured: 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)
Measured: week 12
transfer to neonatal ICU
neonatal outcomes: transfer to neonatal ICU
Measured: 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).
Measured: Week 8; Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start7 Aug 2020
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter double-blind randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304625
- Sponsor's protocol ID
- CHUBX 2018/64
- Acronym
- TRAAPrevia
- Status last verified
- Feb 2025
- First submitted
- 9 Mar 2020
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40448004Larson 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.
PubMed 39162220
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA: a Multicenter Randomised, Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04304625
- Acronym / sponsor ID
- TRAAPrevia / CHUBX 2018/64
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum hemorrhage, tranexamix acid, placenta previa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,380 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Multicenter double-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic Acid / Sodium chlorideAfter 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 | Placebo comparator | Drug: Tranexamic Acid / Sodium chlorideAfter 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid / Sodium chlorideAfter 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 | Placebo, Tranexamic acid |
Primary outcome
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.
20 secondary outcomes
gravimetrically estimated blood loss
Time frame: Baseline
Occurrence of calculated blood loss > 1000ml.
Time frame: Baseline
Occurrence of calculated blood loss > 1500ml.
Time frame: Baseline
mean calculated blood loss
Time frame: Baseline
linically significant PPH
Time frame: Baseline
shock index
Time frame: 15, 30, 45, 60 and 120 minutes after birth
supplementary uterotonic treatment
Time frame: Baseline
iron sucrose perfusion
Time frame: Baseline
red blood cell units transfusion
Time frame: Baseline
number of transfusion
Time frame: Baseline
arterial embolisation
Time frame: Baseline
maternal postpartum transfer
Time frame: Baseline
change in peripartum Hb
Time frame: day 2
change in peripartum Ht
Time frame: day 2
proportion of breastfeeding at hospital discharge
Time frame: Baseline
maternal death for any cause
Time frame: Baseline
mild adverse reactions of TXA
Time frame: Hospitalization stay
thromboembolic events
Time frame: week 12
transfer to neonatal ICU
Time frame: Baseline
Women's satisfaction and psychological status
Time frame: Week 8; Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 40448004Sentilhes 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.
- Derived from this study: PubMed 39162220Larson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurélie Darmaillacq contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid / Sodium chloride in people with Postpartum Hemorrhage, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Loic Sentilhes, MD, PhD (+335 56 79 55 79, loic.sentilhes@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of red blood cell transfusion (binary outcome) between delivery of child and discharge from postpartum hospital stay. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304625, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.