Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02775773
Recruitment Status : Unknown
Verified May 2016 by Azienda U.S.L. 1 di Massa e Carrara.
Recruitment status was:  Active, not recruiting
First Posted : May 18, 2016
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Azienda U.S.L. 1 di Massa e Carrara

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.

Condition or disease Intervention/treatment Phase
Post Partum Haemorrhage Drug: Tranexamic Acid Drug: Oxytocin Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: arm A (TXA)
2 vials (=1 gram ) of Tranexamic Acid administered slow intravenous infusion within 5 minutes from the delivery(third stage after labor)
Drug: Tranexamic Acid
2 vials ( =1 gram) of Tranexamic Acid slow intravenous infusion administered within 5 minutes from the delivery (third stage after labor)
Other Name: TXA

Active Comparator: arm B (OXY)
2 vials (=10 IU/International Unit) of oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)
Drug: Oxytocin
2 vials (=10 IU/International Unit) of Oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)
Other Name: OXY




Primary Outcome Measures :
  1. assessment of total blood loss expressed in mL [ Time Frame: immediately after delivery ]
    global blood loss > 500 mL

  2. assessment of total blood loss expressed in mL [ Time Frame: two hours after delivery ]
    global blood loss > 500 mL


Secondary Outcome Measures :
  1. assessment of the number of hemodynamic changes [ Time Frame: two hours after delivery ]
    hypotension (number of women with Arterial Pressure < 100/60 mm/Hg )

  2. assessment of the number of hemodynamic changes [ Time Frame: immediately after delivery ]
    increased heart rate (number of women with Heart Rate > 60 bpm )

  3. assessment of the need of using additional uterotonic [ Time Frame: immediately after delivery ]
    administration additional drug for the treatment of PPH

  4. assessment of the need of using additional uterotonic [ Time Frame: two hours after delivery ]
    administration additional drug for the treatment of PPH

  5. assessment the need for surgical manoeuvres for the bleeding control [ Time Frame: immediately after ]
    need of intrauterine balloon or uterine compression sutures for surgical treatment of the PPH or hysterectomy

  6. assessment the need for surgical manoeuvres for the bleeding control [ Time Frame: two hours after ]
    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

  7. assessment the need for the blood transfusions [ Time Frame: two days after delivery ]
    Hb <7 g/dL

  8. evaluation of the number of cases in which the following was seen verified: [ Time Frame: two days after delivery ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 )

Layout table for additonal information
Responsible Party: Azienda U.S.L. 1 di Massa e Carrara
ClinicalTrials.gov Identifier: NCT02775773     History of Changes
Other Study ID Numbers: Azenda USLToscana Nord Ovest
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Azienda U.S.L. 1 di Massa e Carrara:
TXA
PPH
Additional relevant MeSH terms:
Layout table for MeSH terms
Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Tranexamic Acid
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants