Immediate Postpartum HemorrhagePhase 3TRAAPNCT02302456
Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery
A Phase 3 study testing Tranexamic Acid in people with Immediate Postpartum Hemorrhage, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Immediate Postpartum Hemorrhage
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,079 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Apr 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 18 years
- Planned vaginal delivery
- Term ≥ 35 weeks of gestation
- Singleton pregnancy
- Informed consent form signed
Who cannot join
- History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombosis.
- History of epilepsy or seizure
- Any known cardiovascular, renal, liver disorders
- Auto-immune disease
- Sickle cell disease
- Severe hemorrhagic disease
Show all 14Show fewer
- Placenta previa
- Abnormally invasive placenta (placenta accreta/increta/percreta)
- Abruptio placentae
- Eclampsia; hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome
- Multiple pregnancy
- In utero foetal death
- Administration of Low-Molecular-Weight Heparin or antiplatelet agents seven days before delivery
- Poor understanding of the French language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery: a Multicenter Randomised Double Blind Placebo Controlled Trial
The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin.
Read the detailed description
Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one quarter of all maternal deaths worldwide. Its incidence estimates in the literature vary widely, from 3% to 15% of deliveries. Uterotonics after birth are the only intervention that has been shown to be effective for PPH prevention. Tranexamic acid (TXA), an antifibrinolytic agent, has therefore been investigated as a potentially useful complement to uterotonics for prevention because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. Randomized controlled trials for PPH prevention after cesarean (n=10) and vaginal (n=2) deliveries showed that women who had received TXA had a significantly lesser amount of postpartum blood loss without any increase in severe maternal adverse effect. However, overall, the quality of these trials was poor, and they were not designed to test the effect of TXA on the reduction of PPH incidence, nor on the incidence of rare but severe adverse effects. Large, adequately powered multicenter randomized controlled trials are required before the widespread use of TXA for preventing PPH can be recommended.
The investigators propose a multicentre randomised, double-blind, placebo-controlled trial, with two parallel groups.
Individual information on the trial will be provided to women in late pregnancy during prenatal visits. This information will be repeated when the women arrive in the delivery room; the women then will confirm their participation and provide informed written consent before delivery, when, in the opinion of the investigator, the woman is likely to have a vaginal delivery with a minimum of 4 cm of cervix dilatation.
The intervention will be the intravenous administration of a 10-ml blinded ampoule of the study drug (either 1g TXA or placebo according to the randomisation order), slowly (over 30-60 seconds), within 2 minutes after birth and prophylactic oxytocin administration, and once the cord has been clamped.
All other aspects of management of the third stage will be identical in both arms:
- Routine prophylactic intravenous injection of 5 IU oxytocin at delivery of the anterior shoulder or within 2 minutes after birth
- Placement of a graduated (100 mL graduation) collector bag just after birth, left in place until the birth attendant judges that bleeding has stopped, and always at least for 15 minutes. When a woman is included in the trial, a bag will be prepared and ready to be put in place as soon as the baby is born and placed on the mother's belly; if needed, a second staff person will be present to help in managing both the baby and the bag. This will make it possible to collect and measure vaginal blood loss objectively during the immediate postpartum.
- Manual removal of the placenta at 30 minutes after birth if not expelled in absence of bleeding.
- Rapid suturing of the episiotomy, in accordance with good clinical practices
- Systematic use of uterotonic drugs after third stage of labor is not recommended.
- Controlled cord traction (CCT) will be left at the discretion of the practitioner.
If PPH occurs, standardised management will be provided according to the department's protocol. In particular, the use of TXA for the treatment of PPH will be allowed and left at the discretion of the practitioner according to the department's protocol.
The duration of the participation of each patient included in the trial will be from inclusion through 3 months postpartum.
The planned total duration of the trial will be 34 months including 23 months of patient inclusion
- Conditions
- Immediate Postpartum Hemorrhage
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- Immediate postpartum hemorrhage, tranexamic acid, prevention
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Intravenous administration of a 10 mL solution containing 1g of tranexamic acid within 2 minutes of birth and routine prophylactic IV injection of oxytocin
PlaceboDrug
Intravenous administration of 10 mL of 0.9% sodium chloride solution within 2 minutes of birth and routine prophylactic IV injection of oxytocin
| Study group | Role | What they receive |
|---|---|---|
| TXA | Experimental | Intravenous administration of 1g of tranexamic acid within 2 minutes after birth and prophylactic oxytocin administration Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Intravenous administration of placebo within 2 minutes after birth and prophylactic oxytocin administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PPH
Incidence of PPH defined by blood loss ≥ 500 ml, measured with a graduated collector bag
Measured: 24 hours after birth
Secondary outcomes (12)
Mean blood loss at 15 minutes after birth
Measured with a collector bag left in place at least 15 minutes to have one measure of blood loss at the same time point in all women
Measured: 15 minutes after birth
Mean total blood loss
Measured at collector bag removal
Measured: Up to 24 hours after birth
Incidence of severe PPH
Incidence of PPH defined by blood loss ≥ 1000 ml, measured with a graduated collector bag
Measured: 24 hours after birth
Need for supplementary uterotonic treatment
Proportion of women requiring supplementary uterotonic treatment including sulprostone
Measured: 24 hours after birth
Postpartum transfusion
Proportion of women transfused in postpartum
Measured: Duration of postpartum hospital stay, an expected average of 3 days
Need for invasive second-line procedures for PPH
Any of the following: arterial embolization, pelvic arterial ligation, uterine compression suture, hysterectomy
Measured: Duration of postpartum hospital stay, an expected average of 3 days
Hemoglobin peripartum delta
Mean difference between the hemoglobin values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells.
Measured: 2 days postpartum
Hematocrit peripartum delta
Mean difference between the hematocrit values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells
Measured: 2 days postpartum
Hemodynamic tolerance
Heart rate, blood pressure
Measured: 15, 30, 45, 60 and 120 minutes after delivery
Mild adverse effects
Nausea, vomiting, phosphenes, dizziness
Measured: Stay in labor ward, an expected average of 2 hours
Tolerance lab tests
Urea, creatinemia, prothrombin time, active prothrombin time, fibrinogenemia, aspartate and alanine transaminase, total bilirubin
Measured: Day 2 postpartum
Severe adverse effects
Deep venous thrombosis, pulmonary embolism, myocardial infarction, renal failure needing dialysis
Measured: Up to 12 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionJan 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Immediate Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Loic SENTILHES, MD PhD, Principal investigator, Department of Obstetrics, Angers University Hospital CenterCatherine DENEUX-THARAUX, MD PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302456
- Sponsor's protocol ID
- PHRC 2013-01
- Acronym
- TRAAP
- Status last verified
- Sep 2017
- First submitted
- 17 Nov 2014
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Novikova N, Hofmeyr GJ. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007872. doi: 10.1002/14651858.CD007872.pub2.
PubMed 20614466Peitsidis P, Kadir RA. Antifibrinolytic therapy with tranexamic acid in pregnancy and postpartum. Expert Opin Pharmacother. 2011 Mar;12(4):503-16. doi: 10.1517/14656566.2011.545818. Epub 2011 Feb 4.
PubMed 21294602Sentilhes L, Daniel V, Darsonval A, Deruelle P, Vardon D, Perrotin F, Le Ray C, Senat MV, Winer N, Maillard F, Deneux-Tharaux C. Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial. BMC Pregnancy Childbirth. 2015 Jun 14;15:135. doi: 10.1186/s12884-015-0573-5.
PubMed 26071040Sentilhes L, Lasocki S, Ducloy-Bouthors AS, Deruelle P, Dreyfus M, Perrotin F, Goffinet F, Deneux-Tharaux C. Tranexamic acid for the prevention and treatment of postpartum haemorrhage. Br J Anaesth. 2015 Apr;114(4):576-87. doi: 10.1093/bja/aeu448. Epub 2015 Jan 8.
PubMed 25571934Sentilhes L, Winer N, Azria E, Senat MV, Le Ray C, Vardon D, Perrotin F, Desbriere R, Fuchs F, Kayem G, Ducarme G, Doret-Dion M, Huissoud C, Bohec C, Deruelle P, Darsonval A, Chretien JM, Seco A, Daniel V, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery. N Engl J Med. 2018 Aug 23;379(8):731-742. doi: 10.1056/NEJMoa1800942.
PubMed 30134136
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery: a Multicenter Randomised Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02302456
- Acronym / sponsor ID
- TRAAP / PHRC 2013-01
- Conditions
- Immediate Postpartum Hemorrhage
- Keywords
- Immediate postpartum hemorrhage, tranexamic acid, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,079 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 27 Nov 2014 (estimated)
- 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.
The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin.
Detailed description
Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one quarter of all maternal deaths worldwide. Its incidence estimates in the literature vary widely, from 3% to 15% of deliveries. Uterotonics after birth are the only intervention that has been shown to be effective for PPH prevention. Tranexamic acid (TXA), an antifibrinolytic agent, has therefore been investigated as a potentially useful complement to uterotonics for prevention because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. Randomized controlled trials for PPH prevention after cesarean (n=10) and vaginal (n=2) deliveries showed that women who had received TXA had a significantly lesser amount of postpartum blood loss without any increase in severe maternal adverse effect. However, overall, the quality of these trials was poor, and they were not designed to test the effect of TXA on the reduction of PPH incidence, nor on the incidence of rare but severe adverse effects. Large, adequately powered multicenter randomized controlled trials are required before the widespread use of TXA for preventing PPH can be recommended.
The investigators propose a multicentre randomised, double-blind, placebo-controlled trial, with two parallel groups.
Individual information on the trial will be provided to women in late pregnancy during prenatal visits. This information will be repeated when the women arrive in the delivery room; the women then will confirm their participation and provide informed written consent before delivery, when, in the opinion of the investigator, the woman is likely to have a vaginal delivery with a minimum of 4 cm of cervix dilatation.
The intervention will be the intravenous administration of a 10-ml blinded ampoule of the study drug (either 1g TXA or placebo according to the randomisation order), slowly (over 30-60 seconds), within 2 minutes after birth and prophylactic oxytocin administration, and once the cord has been clamped.
All other aspects of management of the third stage will be identical in both arms:
- Routine prophylactic intravenous injection of 5 IU oxytocin at delivery of the anterior shoulder or within 2 minutes after birth
- Placement of a graduated (100 mL graduation) collector bag just after birth, left in place until the birth attendant judges that bleeding has stopped, and always at least for 15 minutes. When a woman is included in the trial, a bag will be prepared and ready to be put in place as soon as the baby is born and placed on the mother's belly; if needed, a second staff person will be present to help in managing both the baby and the bag. This will make it possible to collect and measure vaginal blood loss objectively during the immediate postpartum.
- Manual removal of the placenta at 30 minutes after birth if not expelled in absence of bleeding.
- Rapid suturing of the episiotomy, in accordance with good clinical practices
- Systematic use of uterotonic drugs after third stage of labor is not recommended.
- Controlled cord traction (CCT) will be left at the discretion of the practitioner.
If PPH occurs, standardised management will be provided according to the department's protocol. In particular, the use of TXA for the treatment of PPH will be allowed and left at the discretion of the practitioner according to the department's protocol.
The duration of the participation of each patient included in the trial will be from inclusion through 3 months postpartum.
The planned total duration of the trial will be 34 months including 23 months of patient inclusion
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA | Experimental | Drug: Tranexamic AcidIntravenous administration of 1g of tranexamic acid within 2 minutes after birth and prophylactic oxytocin administration |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous administration of placebo within 2 minutes after birth and prophylactic oxytocin administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age≥ 18 years
- Planned vaginal delivery
- Term ≥ 35 weeks of gestation
- Singleton pregnancy
- Informed consent form signed
Key exclusion criteria (14 listed)
- History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombosis.
- History of epilepsy or seizure
- Any known cardiovascular, renal, liver disorders
- Auto-immune disease
- Sickle cell disease
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 AcidIntravenous administration of a 10 mL solution containing 1g of tranexamic acid within 2 minutes of birth and routine prophylactic IV injection of oxytocin | Drug | TXA |
| PlaceboIntravenous administration of 10 mL of 0.9% sodium chloride solution within 2 minutes of birth and routine prophylactic IV injection of oxytocin | Drug | Placebo |
Primary outcome
Incidence of PPH
Time frame: 24 hours after birth
Incidence of PPH defined by blood loss ≥ 500 ml, measured with a graduated collector bag
12 secondary outcomes
Mean blood loss at 15 minutes after birth
Time frame: 15 minutes after birth
Mean total blood loss
Time frame: Up to 24 hours after birth
Incidence of severe PPH
Time frame: 24 hours after birth
Need for supplementary uterotonic treatment
Time frame: 24 hours after birth
Postpartum transfusion
Time frame: Duration of postpartum hospital stay, an expected average of 3 days
Need for invasive second-line procedures for PPH
Time frame: Duration of postpartum hospital stay, an expected average of 3 days
Hemoglobin peripartum delta
Time frame: 2 days postpartum
Hematocrit peripartum delta
Time frame: 2 days postpartum
Hemodynamic tolerance
Time frame: 15, 30, 45, 60 and 120 minutes after delivery
Mild adverse effects
Time frame: Stay in labor ward, an expected average of 2 hours
Tolerance lab tests
Time frame: Day 2 postpartum
Severe adverse effects
Time frame: Up to 12 weeks after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Background: PubMed 20614466Novikova N, Hofmeyr GJ. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007872. doi: 10.1002/14651858.CD007872.pub2.
- Background: PubMed 21294602Peitsidis P, Kadir RA. Antifibrinolytic therapy with tranexamic acid in pregnancy and postpartum. Expert Opin Pharmacother. 2011 Mar;12(4):503-16. doi: 10.1517/14656566.2011.545818. Epub 2011 Feb 4.
- Background: PubMed 26071040Sentilhes L, Daniel V, Darsonval A, Deruelle P, Vardon D, Perrotin F, Le Ray C, Senat MV, Winer N, Maillard F, Deneux-Tharaux C. Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial. BMC Pregnancy Childbirth. 2015 Jun 14;15:135. doi: 10.1186/s12884-015-0573-5.
- Background: PubMed 25571934Sentilhes L, Lasocki S, Ducloy-Bouthors AS, Deruelle P, Dreyfus M, Perrotin F, Goffinet F, Deneux-Tharaux C. Tranexamic acid for the prevention and treatment of postpartum haemorrhage. Br J Anaesth. 2015 Apr;114(4):576-87. doi: 10.1093/bja/aeu448. Epub 2015 Jan 8.
- Derived from this study: PubMed 30134136Sentilhes L, Winer N, Azria E, Senat MV, Le Ray C, Vardon D, Perrotin F, Desbriere R, Fuchs F, Kayem G, Ducarme G, Doret-Dion M, Huissoud C, Bohec C, Deruelle P, Darsonval A, Chretien JM, Seco A, Daniel V, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery. N Engl J Med. 2018 Aug 23;379(8):731-742. doi: 10.1056/NEJMoa1800942.
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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. This study is not recruiting at the moment.
Loic SENTILHES, MD PhD principal investigator
Department of Obstetrics, Angers University Hospital Center
Catherine DENEUX-THARAUX, MD PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
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 in people with Immediate Postpartum Hemorrhage, run by University Hospital, Angers 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 6 Sep 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PPH (time frame: 24 hours after birth). 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 NCT02302456, which also lists 5 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 6 Sep 2017.