Postpartum HemorrhagePhase 3TRAAP2NCT03431805
TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery
A Phase 3 study testing Tranexamic Acid Injectable Solution and Sodium Chloride 0.9% in people with Postpartum Hemorrhage, run by University Hospital, Bordeaux at 26 sites in France.
Trial summary
The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS). Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Tranexamic Acid Injectable Solution and Sodium Chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,574 participants
- Where
- 26 sitesFrance
- Study dates
- 3 Mar 2018to 8 Apr 2020
- 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 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- : adult women admitted for a cesarean delivery before or during labor, at a term ≥ 34 weeks,
- hemoglobin level at the last blood sample >9g/dl,
- available blood test for Hb and Ht within one week before caesarean delivery,
- informed signed consent
Who cannot join
- previous thrombotic event or preexisting pro-thrombotic disease,
- epileptic state or history of seizures,
- presence of any chronic or active cardiovascular disease outside hypertension,
- any chronic or active renal disease and chronic or active liver disease at risk thrombotic or hemorrhagic, autoimmune disease,
- sickle cell disease,
- placenta praevia,
Show all 18Show fewer
- placenta accreta/increta/percreta,
- abruption placentae,
- eclampsia,
- HELLP syndrome,
- significant hemorrhage before cesarean section
- in utero fetal death,
- administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery,
- planned general anesthesia,
- hypersensitivity to tranexamic acid or concentrated hydrochloric acid,
- instrumental extraction failure,
- multiple pregnancy with vaginal delivery of the first child,
- poor understanding of the French language.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
CHU Angers
Angers, 49033
CHU Jean Minjoz
Besançon, 25000
CHU Bordeaux
Bordeaux, 33076
CHRU Côte de Nacre
Caen, 14033
CHU Estain
Clermont-Ferrand, 63001
Centre Hospitalier Intercommunal de Créteil
Créteil
Hôpital Saint Joseph Marseille
Marseille, 13008
Hopital Nord
Marseille, 13915
CHU de Montpellier
Montpellier, 34295
CHRU de Nancy
Nancy, 54000
CHU Nantes
Nantes, 44093
CHU Nîmes
Nîmes, 30900
Hôpital Trousseau
Paris, 75012
Hôpital Saint Joseph Paris
Paris, 75014
Maternité de Port-Royal Paris
Paris, 75014
Hôpital universitaire Necker-Enfants malades
Paris, 75015
Hôpital universitaire Robert Debré
Paris, 75019
Hôpital universitaire Kremlin-Bicètre
Paris, 94270
CH de Pau
Pau
Centre Hospitalier Intercommunal Poissy-Saint Germain
Poissy, 78303
CHU Rennes
Rennes, 35033
CHU Charles Nicolle
Rouen, 76000
CHU Saint Etienne
Saint-Etienne, 42270
CHU Strasbourg
Strasbourg, 67098
Hôpital Paule de Viguier CHU Toulouse
Toulouse, 31059
CHU Tours
Tours, 37044
About this study
Official title: TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery :a Multicenter Randomised, Double Blind Placebo Controlled Trial (TRAAP2)
The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).
Read the detailed description
Regarding the prevention of PPH, recent randomized controlled trials (RCTs) of unclear quality have suggested that TXA may reduce blood loss and maternal morbidity, while a Cochrane Collaboration review has concluded, that "TXA (in addition to uterotonic medications) decreases postpartum blood loss and prevents PPH and blood transfusions following vaginal birth and CS in women at low risk of PPH based on studies of mixed quality. Further investigations are needed on efficacy and safety of this regimen for preventing PPH.
Treatment, that is a 10-mL blinded vial of the study drug (either 1g TXA or placebo according to the randomization sequence), will be administered intravenously to the participant women during the third stage of labor of cesarean delivery.
The follow-up visit will take place in the postpartum ward of the maternity unit, on D2 postpartum. This stage will include a venous blood sample to measure plasma concentrations of Hb and Ht, urea and creatinemia, prothrombin time (PT), active prothrombin time (aPTT), aspartate and alanine transaminase, total bilirubin and fibrinogen, and the completion of a self-questionnaire about satisfaction by the women, as well as the assessment of the adverse events.
At 8 weeks postpartum, a self-questionnaire assessing psychological status and well-being will be sent to the women. At 12 weeks postpartum, all participants will be contacted by phone to assess the incidence of thrombotic and any other significant events.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Tranexamic Acid Injectable Solution, Sodium Chloride 0.9%
- Keywords
- Randomized, double blind placebo controlled trial, prevention, tranexamic acid, postpartum hemorrhage, cesarean
- 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 Acid Injectable SolutionDrug
After the routine and prophylactic administration of a uterotonic , 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 woman within 3 minutes after birth, slowly (over 30-60 seconds), once the cord has been clamped.
Sodium Chloride 0.9%Drug
After a routine and prophylactic administration of a uterotonic , 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 afterbirth), slowly (over 30-60 seconds), once the cord has been clamped.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | intravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable) Receives: Drug: Tranexamic Acid Injectable Solution |
| Chloride solution | Placebo comparator | sodium intravenous administration of 10-mL of chloride solution (0.9% -10mL). Receives: Drug: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum hemorrhage
Incidence of PPH defined by a calculated blood loss > 1000mL [Calculated estimated blood loss = estimated blood volume × (preoperative Ht - postoperative Ht)/preoperative Ht (where estimated blood volume (mL) = weight (Kg) × 85)] or red blood cell transfusion up to day 2 postpartum. Preoperative Ht will be the most recent Ht within one week before delivery. Postoperative Ht will be measured at D2
Measured: day 2
Secondary outcomes (43)
mean calculated blood loss > 500mL
Measured: day 2
mean calculated blood loss > 1500mL
Measured: day 2
total mean calculated blood loss
Measured: day 2
mean gravimetrically estimated blood loss
by measuring the suction volume and swab weight; proportion of women requiring supplementary uterotonic treatment including sulprostone
Measured: 6 hours
incidence of postpartum transfusion
Measured: day 2
Mean or median number of units of red blood cells transfused
Measured: day 2
incidence of arterial embolisation or emergency surgery for PPH
Measured: 3 months
mean peripartum change in haemoglobin
difference between the most recent Hb within one week before delivery and at day 2 postpartum
Measured: day 2
mean peripartum change in hematocrit
difference between the most recent Ht within one week before delivery and at day 2 postpartum
Measured: day 2
heart rate
bpm
Measured: 15, 30, 45, 60 and 120 minutes after delivery
diastolic blood pressure
mmHg
Measured: 15, 30, 45, 60 and 120 minutes after delivery
systolic blood pressure
mmHg
Measured: 15, 30, 45, 60 and 120 minutes after delivery
number of participants with nausea reported by caregivers
Measured: 6 hours
number of participants with vomiting reported by caregivers
Measured: 6 hours
number of participants with phosphenes reported by caregivers
Measured: 6 hours
number of participants with dizziness reported by caregivers
Measured: 6 hours
creatinemia
micromol/L
Measured: day 2
urea
g/L
Measured: day 2
prothrombin time (PT)
%
Measured: day 2
aspartate transaminase
IU/L
Measured: day 2
alanine transaminase
IU/L
Measured: day 2
total bilirubin
micromol/L
Measured: day 2
total fibrinogen
g/L
Measured: day 2
number of participants with deep venous thrombosis confirmed by paraclinical exams
Measured: within twelve weeks after the delivery
number of participants with pulmonary embolism confirmed by paraclinical exams
Measured: within twelve weeks after the delivery
number of participants with myocardial infarction confirmed by paraclinical exams
Measured: within twelve weeks after the delivery
number of participants with any thrombotic event confirmed by paraclinical exams
Measured: within twelve weeks after the delivery
seizure
Measured: within twelve weeks after the delivery
renal failure
defined by the need for dialysis
Measured: within twelve weeks after the delivery
women's satisfaction
assessed by a self-administered questionnaire
Measured: day 2 and weeks 8 postpartum
Provider-assessed clinically significant PPH
Measured: day 2
Hb drop > 2g/DL
Measured: day 2
Active prothrombin time (aPTT)
Measured: day 2
aspartate transaminase > 2N
Measured: day 2
alanine transaminase > 2N (day 2)
Measured: day 2
gravimetrically estimated blood loss > 500mL
Measured: day 2
gravimetrically estimated blood loss > 1000 mL
Measured: day 2
Shock
Measured: day 2
Transfer to Intensive Care Unit
Measured: twelve weeks after delivery
Death from any cause
Measured: 42 days postpartum
supplementary uterotonic treatment
proportion of women requiring supplementary uterotonic treatment
Measured: day 2
iron sucrose perfusion
incidence of iron sucrose perfusion
Measured: discharge from hospital
mean gravimetrically estimated blood loss
Measured: at the end of the cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start3 Mar 2018
- Primary completion14 Jan 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,574 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431805
- Sponsor's protocol ID
- CHUBX 2015/41
- Other IDs
- 2017-001144-36, 2017
- Acronym
- TRAAP2
- Status last verified
- Apr 2020
- First submitted
- 30 Jan 2018
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sentilhes L, Benard A, Madar H, Froeliger A, Petit S, Deneux-Tharaux C; TRAAP2 study group. Tranexamic acid for reduction of blood loss after Caesarean delivery: a cost-effectiveness analysis of the TRAAP2 trial. Br J Anaesth. 2023 Nov;131(5):893-900. doi: 10.1016/j.bja.2023.07.028. Epub 2023 Sep 9.
PubMed 37690946Sentilhes L, Senat MV, Le Lous M, Winer N, Rozenberg P, Kayem G, Verspyck E, Fuchs F, Azria E, Gallot D, Korb D, Desbriere R, Le Ray C, Chauleur C, de Marcillac F, Perrotin F, Parant O, Salomon LJ, Gauchotte E, Bretelle F, Sananes N, Bohec C, Mottet N, Legendre G, Letouzey V, Haddad B, Vardon D, Madar H, Mattuizzi A, Daniel V, Regueme S, Roussillon C, Benard A, Georget A, Darsonval A, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery. N Engl J Med. 2021 Apr 29;384(17):1623-1634. doi: 10.1056/NEJMoa2028788.
PubMed 33913639Sentilhes L, Daniel V, Deneux-Tharaux C; TRAAP2 Study Group and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). TRAAP2 - TRAnexamic Acid for Preventing postpartum hemorrhage after cesarean delivery: a multicenter randomized, doubleblind, placebo- controlled trial - a study protocol. BMC Pregnancy Childbirth. 2020 Jan 31;20(1):63. doi: 10.1186/s12884-019-2718-4.
PubMed 32005192
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery :a Multicenter Randomised, Double Blind Placebo Controlled Trial (TRAAP2)
- ClinicalTrials.gov ID
- NCT03431805
- Acronym / sponsor ID
- TRAAP2 / CHUBX 2015/41
- Conditions
- Postpartum Hemorrhage
- Keywords
- Randomized, double blind placebo controlled trial, prevention, tranexamic acid, postpartum hemorrhage, cesarean
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,574 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 13 Feb 2018 (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.
The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).
Detailed description
Regarding the prevention of PPH, recent randomized controlled trials (RCTs) of unclear quality have suggested that TXA may reduce blood loss and maternal morbidity, while a Cochrane Collaboration review has concluded, that "TXA (in addition to uterotonic medications) decreases postpartum blood loss and prevents PPH and blood transfusions following vaginal birth and CS in women at low risk of PPH based on studies of mixed quality. Further investigations are needed on efficacy and safety of this regimen for preventing PPH.
Treatment, that is a 10-mL blinded vial of the study drug (either 1g TXA or placebo according to the randomization sequence), will be administered intravenously to the participant women during the third stage of labor of cesarean delivery.
The follow-up visit will take place in the postpartum ward of the maternity unit, on D2 postpartum. This stage will include a venous blood sample to measure plasma concentrations of Hb and Ht, urea and creatinemia, prothrombin time (PT), active prothrombin time (aPTT), aspartate and alanine transaminase, total bilirubin and fibrinogen, and the completion of a self-questionnaire about satisfaction by the women, as well as the assessment of the adverse events.
At 8 weeks postpartum, a self-questionnaire assessing psychological status and well-being will be sent to the women. At 12 weeks postpartum, all participants will be contacted by phone to assess the incidence of thrombotic and any other significant events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic Acid Injectable Solutionintravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable) |
| Chloride solution | Placebo comparator | Drug: Sodium Chloride 0.9%sodium intravenous administration of 10-mL of chloride solution (0.9% -10mL). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- : adult women admitted for a cesarean delivery before or during labor, at a term ≥ 34 weeks,
- hemoglobin level at the last blood sample >9g/dl,
- available blood test for Hb and Ht within one week before caesarean delivery,
- informed signed consent
Key exclusion criteria (18 listed)
- previous thrombotic event or preexisting pro-thrombotic disease,
- epileptic state or history of seizures,
- presence of any chronic or active cardiovascular disease outside hypertension,
- any chronic or active renal disease and chronic or active liver disease at risk thrombotic or hemorrhagic, autoimmune 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 Acid Injectable SolutionAfter the routine and prophylactic administration of a uterotonic , 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 woman within 3 minutes after birth, slowly (over 30-60 seconds), once the cord has been clamped. | Drug | Tranexamic acid |
| Sodium Chloride 0.9%After a routine and prophylactic administration of a uterotonic , 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 afterbirth), slowly (over 30-60 seconds), once the cord has been clamped. | Drug | Chloride solution |
Primary outcome
postpartum hemorrhage
Time frame: day 2
Incidence of PPH defined by a calculated blood loss > 1000mL [Calculated estimated blood loss = estimated blood volume × (preoperative Ht - postoperative Ht)/preoperative Ht (where estimated blood volume (mL) = weight (Kg) × 85)] or red blood cell transfusion up to day 2 postpartum. Preoperative Ht will be the most recent Ht within one week before delivery. Postoperative Ht will be measured at D2
43 secondary outcomes
mean calculated blood loss > 500mL
Time frame: day 2
mean calculated blood loss > 1500mL
Time frame: day 2
total mean calculated blood loss
Time frame: day 2
mean gravimetrically estimated blood loss
Time frame: 6 hours
incidence of postpartum transfusion
Time frame: day 2
Mean or median number of units of red blood cells transfused
Time frame: day 2
incidence of arterial embolisation or emergency surgery for PPH
Time frame: 3 months
mean peripartum change in haemoglobin
Time frame: day 2
mean peripartum change in hematocrit
Time frame: day 2
heart rate
Time frame: 15, 30, 45, 60 and 120 minutes after delivery
diastolic blood pressure
Time frame: 15, 30, 45, 60 and 120 minutes after delivery
systolic blood pressure
Time frame: 15, 30, 45, 60 and 120 minutes after delivery
number of participants with nausea reported by caregivers
Time frame: 6 hours
number of participants with vomiting reported by caregivers
Time frame: 6 hours
number of participants with phosphenes reported by caregivers
Time frame: 6 hours
number of participants with dizziness reported by caregivers
Time frame: 6 hours
creatinemia
Time frame: day 2
urea
Time frame: day 2
prothrombin time (PT)
Time frame: day 2
aspartate transaminase
Time frame: day 2
alanine transaminase
Time frame: day 2
total bilirubin
Time frame: day 2
total fibrinogen
Time frame: day 2
number of participants with deep venous thrombosis confirmed by paraclinical exams
Time frame: within twelve weeks after the delivery
number of participants with pulmonary embolism confirmed by paraclinical exams
Time frame: within twelve weeks after the delivery
number of participants with myocardial infarction confirmed by paraclinical exams
Time frame: within twelve weeks after the delivery
number of participants with any thrombotic event confirmed by paraclinical exams
Time frame: within twelve weeks after the delivery
seizure
Time frame: within twelve weeks after the delivery
renal failure
Time frame: within twelve weeks after the delivery
women's satisfaction
Time frame: day 2 and weeks 8 postpartum
Provider-assessed clinically significant PPH
Time frame: day 2
Hb drop > 2g/DL
Time frame: day 2
Active prothrombin time (aPTT)
Time frame: day 2
aspartate transaminase > 2N
Time frame: day 2
alanine transaminase > 2N (day 2)
Time frame: day 2
gravimetrically estimated blood loss > 500mL
Time frame: day 2
gravimetrically estimated blood loss > 1000 mL
Time frame: day 2
Shock
Time frame: day 2
Transfer to Intensive Care Unit
Time frame: twelve weeks after delivery
Death from any cause
Time frame: 42 days postpartum
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 12 May 2026.
- Derived from this study: PubMed 37690946Sentilhes L, Benard A, Madar H, Froeliger A, Petit S, Deneux-Tharaux C; TRAAP2 study group. Tranexamic acid for reduction of blood loss after Caesarean delivery: a cost-effectiveness analysis of the TRAAP2 trial. Br J Anaesth. 2023 Nov;131(5):893-900. doi: 10.1016/j.bja.2023.07.028. Epub 2023 Sep 9.
- Derived from this study: PubMed 33913639Sentilhes L, Senat MV, Le Lous M, Winer N, Rozenberg P, Kayem G, Verspyck E, Fuchs F, Azria E, Gallot D, Korb D, Desbriere R, Le Ray C, Chauleur C, de Marcillac F, Perrotin F, Parant O, Salomon LJ, Gauchotte E, Bretelle F, Sananes N, Bohec C, Mottet N, Legendre G, Letouzey V, Haddad B, Vardon D, Madar H, Mattuizzi A, Daniel V, Regueme S, Roussillon C, Benard A, Georget A, Darsonval A, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery. N Engl J Med. 2021 Apr 29;384(17):1623-1634. doi: 10.1056/NEJMoa2028788.
- Derived from this study: PubMed 32005192Sentilhes L, Daniel V, Deneux-Tharaux C; TRAAP2 Study Group and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). TRAAP2 - TRAnexamic Acid for Preventing postpartum hemorrhage after cesarean delivery: a multicenter randomized, doubleblind, placebo- controlled trial - a study protocol. BMC Pregnancy Childbirth. 2020 Jan 31;20(1):63. doi: 10.1186/s12884-019-2718-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites 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 Injectable Solution and Sodium Chloride 0.9% in people with Postpartum Hemorrhage, run by University Hospital, Bordeaux at 26 sites 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 4 inclusion and 18 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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?
postpartum hemorrhage (time frame: day 2). 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 NCT03431805, which also lists 3 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 12 May 2026.