Postpartum HemorrhagePhase 3TRANOXY2015NCT02503319
Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH (TRANOXY2015)
A Phase 3 study testing Tranexamic Acid and Oxytocin in people with Postpartum Hemorrhage, run by Azienda U.S.L. 1 di Massa e Carrara.
Trial summary
The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum hemorrhage (PPH). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Tranexamic Acid and Oxytocin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2016
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects at the end of pregnancy ( 37-42 w ) at low risk of PPH Mean by low-risk of PPH subjects without any of the following risk factors : hypertension/preeclampsia, placental abruption during pregnancy , placenta previa , tocolysis two hours before delivery, multiple pregnancy , previous PPH, obesity ( BMI > 35 ), anemia (Hb < 7 g/dL), elective caesarean section , induction of labor, retention of placental material , polyhydramnios , fever during labor, use of high doses of heparin low molecular weight.
- Subjects full capacity and the willingness to give written informed consent .
Who cannot join
- Subjects with preterm pregnancy (<37 weeks ) or with prolonged pregnancy ( > 42 weeks )
- Subjects at the end of pregnancy ( 37 weeks - 42 weeks ) with the following risk factors for PPH (Tab1)
- multiple pregnancy
- history of thromboembolic disease or high incidence of thromboembolic events in family history ( patients at high risk of thrombophilia )
- Patients with Long - QT syndrome or who are taking drugs that cause QT prolongation
- Intrauterine fetal Death
Show all 22Show fewer
- epilepsy
- autoimmune disease Tab1 medical history :
- Placental abruption during pregnancy
- placenta previa
- Hypertension / preeclampsia
- previous PPH
- polyhydramnios
- Obesity ( BMI > 35 )
- Anemia ( < 7 g / dL )
- Detectable in labor:
- Elective caesarean section
- Tocolysis two hours before delivery
- Induction of labor
- Retention of placental material
- Fever during labor
- Use of low molecular weight heparin
About this study
Official title: Clinical Study,Longitudinal,Controlled, Randomized, Open-label, Phase III,to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the Post Partum Hemorrhage (PHH) in Patients at the End of Pregnancy (37-42 w) at Low Risk of PPH
The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal delivery ( the bleeding is defined severe if it exceeds 1000 mL). PPH is called "primary" when blood loss arose within 24 hours after birth.
This is a open-trial randomized, longitudinal, controlled that including 486 subjects .
Read the detailed description
This trial includes three arms of treatment :
- arm A (IMP1Test): TXA 500mg/ 2 vials (1 gr) oral within 5 minutes from the delivery (third stage af labor)
- arm B (IMP2Test): TXA 500 mg/ 2 vials (1 gr) slow intravenous infusion 1ml/min within 5 minutes from the delivery(third stage af labor)
- arm C (control): OXY 5 IU/ml/ 2 vials (10 International Unit) intramuscularly within 5 minutes from the delivery (third stage af labor) The clamping of the umbilical cord will be executed immediately after birth The randomization 1:1:1 (block design), generated by the computer. Primary outcomes: assessment of total blood loss expressed in mL
- immediately after delivery
- two hours after delivery
The measurement of the overall blood loss at delivery (ml) will be performed by the graduated bag, immediately after birth.
The measurement two hours after delivery will be performed by weighing of the adsorbent material [ N.ml = N. gr indicated by the balance - dry weight of the sanitary napkin]. The overall loss in blood measured (ml) two hours of delivery will then be performed by adding the two collections.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Tranexamic Acid, Oxytocin
- 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
Also called TXA
2 vials ( =1 gram) of Tranexamic Acid oral administered within 5 minutes from the delivery (third stage after labor)
2 vials (=1 gram ) of Tranexamic Acid administered slow intravenous infusion within 5 minutes from the delivery (third stage after labor)
Tranexamic AcidDrug
Also called TXA
2 vials ( =1 gram) of Tranexamic Acid slow intravenous infusion administered within 5 minutes from the delivery (third stage after labor)
OxytocinDrug
Also called OXY
2 vials (=10 IU/International Unit) of oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)
| Study group | Role | What they receive |
|---|---|---|
| arm A | Experimental | 2 vials ( =1 gram) of Tranexamic Acid oral administered within 5 minutes from the delivery (third stage after labor) Receives: Drug: Tranexamic Acid |
| arm B | Experimental | 2 vials (=1 gram ) of Tranexamic Acid administered slow intravenous infusion within 5 minutes from the delivery(third stage after labor) Receives: Drug: Tranexamic Acid |
| arm C | Active comparator | 2 vials (=10 IU/International Unit) of oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor) Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of total blood loss expressed in mL
global blood loss > 500 mL
Measured: immediately after delivery
assessment of total blood loss expressed in mL
global blood loss > 500 mL
Measured: two hours after delivery
Secondary outcomes (9)
assessment of the number of hemodynamic changes
hypotension (number of women with Arterial Pressure < 100/60 mm/Hg )
Measured: immediately after delivery
assessment of the number of hemodynamic changes
hypotension (number of women with Arterial Pressure < 100/60 mm/Hg )
Measured: two hours after delivery
assessment of the number of hemodynamic changes
increased heart rate (number of women with Heart Rate > 60 bpm )
Measured: immediately after delivery
assessment of the number of hemodynamic changes
increased heart rate (number of women with Heart Rate > 60 bpm )
Measured: two hours after delivery
assessment of the need of using additional uterotonic
administration additional drug for the treatment of PPH
Measured: immediately after delivery
assessment of the need of using additional uterotonic
administration additional drug for the treatment of PPH
Measured: two hours after delivery
assessment the need for surgical manoeuvres for the bleeding control
need of intrauterine balloon or uterine compression sutures for surgical treatment of the PPH or hysterectomy
Measured: immediately after delivery
assessment the need for surgical manoeuvres for the bleeding control
need of intrauterine balloon or uterine compression sutures for surgical treatment of the PPH or hysterectomy
Measured: two hours after delivery
assessment the need for the blood transfusions
Hb <7 g/dL
Measured: two days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Authorization denied
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda U.S.L. 1 di Massa e Carrara
- Sponsor type
- University, hospital or other
- Collaborators
- Dr.Antonio Franco Ragusa
- Responsible party
- Sponsor
- Investigators
- Antonio Ragusa, Dr, Principal investigator, Azienda USL1 di Massa e Carrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503319
- Sponsor's protocol ID
- AzUSL1 di Massa e Carrara
- Acronym
- TRANOXY2015
- Status last verified
- Jan 2016
- First submitted
- 26 Jun 2015
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study,Longitudinal,Controlled, Randomized, Open-label, Phase III,to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the Post Partum Hemorrhage (PHH) in Patients at the End of Pregnancy (37-42 w) at Low Risk of PPH
- ClinicalTrials.gov ID
- NCT02503319
- Acronym / sponsor ID
- TRANOXY2015 / AzUSL1 di Massa e Carrara
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Authorization denied
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Azienda U.S.L. 1 di Massa e CarraraUniversity, hospital or other
- Collaborators
- Dr.Antonio Franco Ragusa
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Jul 2015 (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 was to evaluate that the tranexamic acid (TXA)Intravenous and oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal delivery ( the bleeding is defined severe if it exceeds 1000 mL). PPH is called "primary" when blood loss arose within 24 hours after birth.
This is a open-trial randomized, longitudinal, controlled that including 486 subjects .
Detailed description
This trial includes three arms of treatment :
- arm A (IMP1Test): TXA 500mg/ 2 vials (1 gr) oral within 5 minutes from the delivery (third stage af labor)
- arm B (IMP2Test): TXA 500 mg/ 2 vials (1 gr) slow intravenous infusion 1ml/min within 5 minutes from the delivery(third stage af labor)
- arm C (control): OXY 5 IU/ml/ 2 vials (10 International Unit) intramuscularly within 5 minutes from the delivery (third stage af labor) The clamping of the umbilical cord will be executed immediately after birth The randomization 1:1:1 (block design), generated by the computer. Primary outcomes: assessment of total blood loss expressed in mL
- immediately after delivery
- two hours after delivery
The measurement of the overall blood loss at delivery (ml) will be performed by the graduated bag, immediately after birth.
The measurement two hours after delivery will be performed by weighing of the adsorbent material [ N.ml = N. gr indicated by the balance - dry weight of the sanitary napkin]. The overall loss in blood measured (ml) two hours of delivery will then be performed by adding the two collections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arm A | Experimental | Drug: Tranexamic Acid2 vials ( =1 gram) of Tranexamic Acid oral administered within 5 minutes from the delivery (third stage after labor) |
| arm B | Experimental | Drug: Tranexamic Acid2 vials (=1 gram ) of Tranexamic Acid administered slow intravenous infusion within 5 minutes from the delivery(third stage after labor) |
| arm C | Active comparator | Drug: Oxytocin2 vials (=10 IU/International Unit) of oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects at the end of pregnancy ( 37-42 w ) at low risk of PPH Mean by low-risk of PPH subjects without any of the following risk factors : hypertension/preeclampsia, placental abruption during pregnancy , placenta previa , tocolysis two hours before delivery, multiple pregnancy , previous PPH, obesity ( BMI > 35 ), anemia (Hb < 7 g/dL), elective caesarean section , induction of labor, retention of placental material , polyhydramnios , fever during labor, use of high doses of heparin low molecular weight.
- Subjects full capacity and the willingness to give written informed consent .
Key exclusion criteria (22 listed)
- Subjects with preterm pregnancy (<37 weeks ) or with prolonged pregnancy ( > 42 weeks )
- Subjects at the end of pregnancy ( 37 weeks - 42 weeks ) with the following risk factors for PPH (Tab1)
- multiple pregnancy
- history of thromboembolic disease or high incidence of thromboembolic events in family history ( patients at high risk of thrombophilia )
- Patients with Long - QT syndrome or who are taking drugs that cause QT prolongation
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 AcidAlso: TXA2 vials ( =1 gram) of Tranexamic Acid oral administered within 5 minutes from the delivery (third stage after labor) 2 vials (=1 gram ) of Tranexamic Acid administered slow intravenous infusion within 5 minutes from the delivery (third stage after labor) | Drug | arm A |
| Tranexamic AcidAlso: TXA2 vials ( =1 gram) of Tranexamic Acid slow intravenous infusion administered within 5 minutes from the delivery (third stage after labor) | Drug | arm B |
| OxytocinAlso: OXY2 vials (=10 IU/International Unit) of oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor) | Drug | arm C |
Primary outcome
assessment of total blood loss expressed in mL
Time frame: immediately after delivery
global blood loss > 500 mL
assessment of total blood loss expressed in mL
Time frame: two hours after delivery
global blood loss > 500 mL
9 secondary outcomes
assessment of the number of hemodynamic changes
Time frame: immediately after delivery
assessment of the number of hemodynamic changes
Time frame: two hours after delivery
assessment of the number of hemodynamic changes
Time frame: immediately after delivery
assessment of the number of hemodynamic changes
Time frame: two hours after delivery
assessment of the need of using additional uterotonic
Time frame: immediately after delivery
assessment of the need of using additional uterotonic
Time frame: two hours after delivery
assessment the need for surgical manoeuvres for the bleeding control
Time frame: immediately after delivery
assessment the need for surgical manoeuvres for the bleeding control
Time frame: two hours after delivery
assessment the need for the blood transfusions
Time frame: two days after delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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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.
Antonio Ragusa, Dr principal investigator
Azienda USL1 di Massa e Carrara
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid and Oxytocin in people with Postpartum Hemorrhage, run by Azienda U.S.L. 1 di Massa e Carrara.
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 2 inclusion and 22 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: withdrawn, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
assessment of total blood loss expressed in mL (time frame: immediately after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.