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AzTrials

Post Partum HaemorrhagePhase 3TRANOXY2016NCT02775773

Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH

A Phase 3 study testing Tranexamic Acid and Oxytocin in people with Post Partum Haemorrhage, run by Azienda U.S.L. 1 di Massa e Carrara at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Post Partum Haemorrhage
What is being tested?
Tranexamic Acid and Oxytocin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 siteItaly
Study dates
30 Jan 2018to 31 Dec 2018
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.Protocol Study, vers.2.0 of 07/05/2016)
  • 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 15Show 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 )

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Department of Ostetricia e Ginecologia-Ospedale delle Apuane

    Massa, MS, 54100

Other trials in Italy

About this study

Official title: Longitudinal Clinical, Controlled, Randomized, Open-label, Phase III Study to Assess the Equivalence of Tranexamic Acid (TXA) vs Oxytocin (OXY) in Reducing Post Partum Haemorrhage (PPH) 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.

Read the detailed description

This trial includes three arms of treatment :

  • arm A (IMP1Test): TXA 500 mg/ 2 vials (1 gr) slow intravenous infusion 1ml/min within 5 minutes from the delivery(third stage af labor)
  • arm B (IMP2Control): 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 (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.

Keywords
TXA, PPH
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 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 groups in NCT02775773
Study groupRoleWhat they receive
arm A (TXA)Experimental2 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 B (OXY)Active comparator2 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.

  1. assessment of total blood loss expressed in mL

    global blood loss > 500 mL

    Measured: immediately after delivery

  2. assessment of total blood loss expressed in mL

    global blood loss > 500 mL

    Measured: two hours after delivery

Secondary outcomes (8)

  1. assessment of the number of hemodynamic changes

    hypotension (number of women with Arterial Pressure < 100/60 mm/Hg )

    Measured: two hours after delivery

  2. assessment of the number of hemodynamic changes

    increased heart rate (number of women with Heart Rate > 60 bpm )

    Measured: immediately after delivery

  3. assessment of the need of using additional uterotonic

    administration additional drug for the treatment of PPH

    Measured: immediately after delivery

  4. assessment of the need of using additional uterotonic

    administration additional drug for the treatment of PPH

    Measured: two hours after delivery

  5. 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

  6. 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 need of intrauterine balloon or uterine compression sutures for surgical treatment of the PPH or hysterectomy

    Measured: two hours after

  7. assessment the need for the blood transfusions

    Hb <7 g/dL

    Measured: two days after delivery

  8. evaluation of the number of cases in which the following was seen verified:

    nausea between delivery and discharge vomiting between birth and discharge headache between birth and discharge dyspnoea between birth and discharge Chest pain between birth and discharge endometritis after delivery (assessed by monitoring body temperature)

    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.

  1. First posted18 May 2016 (estimated)
  2. Study start30 Jan 2018
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

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
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02775773
Sponsor's protocol ID
Azenda USLToscana Nord Ovest
Acronym
TRANOXY2016
Status last verified
Jan 2019
First submitted
16 May 2016
Last updated
8 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ragusa A, Ficarola F, Ferrari A, Spirito N, Ardovino M, Giraldi D, Stuzziero E, Rinaldo D, Procaccianti R, Larciprete G, De Luca C, D'Avino S, Principi G, Angioli R, Svelato A. Tranexamic acid versus oxytocin prophylaxis in reducing post-partum blood loss, in low-risk pregnant women: TRANOXY STUDY, a phase III randomized clinical trial. EClinicalMedicine. 2024 May 31;73:102665. doi: 10.1016/j.eclinm.2024.102665. eCollection 2024 Jul.

    PubMed 38873634

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic Acid and Oxytocin in people with Post Partum Haemorrhage, run by Azienda U.S.L. 1 di Massa e Carrara at 1 site in Italy.

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 15 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 8 Feb 2024. 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 Italy. 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. 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?

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?

On the ClinicalTrials.gov record for NCT02775773, which also lists 1 linked publication.

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.

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