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Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH (TRANOXY2016)

Primary Purpose

Post Partum Haemorrhage

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Oxytocin
Sponsored by
Azienda U.S.L. 1 di Massa e Carrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Partum Haemorrhage focused on measuring TXA, PPH

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 .

Exclusion Criteria:

  • 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
  • Epilepsy
  • Autoimmune disease Tab1 medical history :
  • Placental abruption during pregnancy
  • Placenta previa
  • Hypertension / preeclampsia
  • Previous PPH
  • Polyhydramnios
  • Obesity ( BMI > 35 )
  • Anemia ( < 7 g / dL )

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    arm A (TXA)

    arm B (OXY)

    Arm Description

    2 vials (=1 gram ) of Tranexamic Acid administered slow intravenous infusion within 5 minutes from the delivery(third stage after labor)

    2 vials (=10 IU/International Unit) of oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)

    Outcomes

    Primary Outcome Measures

    assessment of total blood loss expressed in mL
    global blood loss > 500 mL
    assessment of total blood loss expressed in mL
    global blood loss > 500 mL

    Secondary Outcome Measures

    assessment of the number of hemodynamic changes
    hypotension (number of women with Arterial Pressure < 100/60 mm/Hg )
    assessment of the number of hemodynamic changes
    increased heart rate (number of women with Heart Rate > 60 bpm )
    assessment of the need of using additional uterotonic
    administration additional drug for the treatment of PPH
    assessment of the need of using additional uterotonic
    administration additional drug for the treatment of PPH
    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
    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
    assessment the need for the blood transfusions
    Hb <7 g/dL
    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)

    Full Information

    First Posted
    May 16, 2016
    Last Updated
    January 20, 2017
    Sponsor
    Azienda U.S.L. 1 di Massa e Carrara
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02775773
    Brief Title
    Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH
    Acronym
    TRANOXY2016
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    December 31, 2017 (Anticipated)
    Study Completion Date
    December 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Azienda U.S.L. 1 di Massa e Carrara

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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). 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Partum Haemorrhage
    Keywords
    TXA, PPH

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    256 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    arm A (TXA)
    Arm Type
    Experimental
    Arm Description
    2 vials (=1 gram ) of Tranexamic Acid administered slow intravenous infusion within 5 minutes from the delivery(third stage after labor)
    Arm Title
    arm B (OXY)
    Arm Type
    Active Comparator
    Arm Description
    2 vials (=10 IU/International Unit) of oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid
    Other Intervention Name(s)
    TXA
    Intervention Description
    2 vials ( =1 gram) of Tranexamic Acid slow intravenous infusion administered within 5 minutes from the delivery (third stage after labor)
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin
    Other Intervention Name(s)
    OXY
    Intervention Description
    2 vials (=10 IU/International Unit) of Oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)
    Primary Outcome Measure Information:
    Title
    assessment of total blood loss expressed in mL
    Description
    global blood loss > 500 mL
    Time Frame
    immediately after delivery
    Title
    assessment of total blood loss expressed in mL
    Description
    global blood loss > 500 mL
    Time Frame
    two hours after delivery
    Secondary Outcome Measure Information:
    Title
    assessment of the number of hemodynamic changes
    Description
    hypotension (number of women with Arterial Pressure < 100/60 mm/Hg )
    Time Frame
    two hours after delivery
    Title
    assessment of the number of hemodynamic changes
    Description
    increased heart rate (number of women with Heart Rate > 60 bpm )
    Time Frame
    immediately after delivery
    Title
    assessment of the need of using additional uterotonic
    Description
    administration additional drug for the treatment of PPH
    Time Frame
    immediately after delivery
    Title
    assessment of the need of using additional uterotonic
    Description
    administration additional drug for the treatment of PPH
    Time Frame
    two hours after delivery
    Title
    assessment the need for surgical manoeuvres for the bleeding control
    Description
    need of intrauterine balloon or uterine compression sutures for surgical treatment of the PPH or hysterectomy
    Time Frame
    immediately after
    Title
    assessment the need for surgical manoeuvres for the bleeding control
    Description
    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
    Time Frame
    two hours after
    Title
    assessment the need for the blood transfusions
    Description
    Hb <7 g/dL
    Time Frame
    two days after delivery
    Title
    evaluation of the number of cases in which the following was seen verified:
    Description
    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)
    Time Frame
    two days after delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 . Exclusion Criteria: 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 Epilepsy Autoimmune disease Tab1 medical history : Placental abruption during pregnancy Placenta previa Hypertension / preeclampsia Previous PPH Polyhydramnios Obesity ( BMI > 35 ) Anemia ( < 7 g / dL )

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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