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Completed

NCT Number: NCT02775773

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

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Key information

Conditions

Post Partum Haemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Department of Ostetricia e Ginecologia-Ospedale delle Apuane

Massa, MS, 54100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Tranexamic Acid

Drug

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

Other names: TXA

Oxytocin

Drug

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

Other names: OXY

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Azienda U.S.L. 1 di Massa e Carrara

Other

Registry information

Official study 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

Acronym: TRANOXY2016

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 18, 2016
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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