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

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.

Study Overview

• Status: Completed
• Conditions: Post Partum Haemorrhage
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Oxytocin

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.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • MS
    • Massa, MS, Italy, 54100
      • Department of Ostetricia e Ginecologia-Ospedale delle Apuane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: OXY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of total blood loss expressed in mL	global blood loss > 500 mL	immediately after delivery
assessment of total blood loss expressed in mL	global blood loss > 500 mL	two hours after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of the number of hemodynamic changes	hypotension (number of women with Arterial Pressure < 100/60 mm/Hg )	two hours after delivery
assessment of the number of hemodynamic changes	increased heart rate (number of women with Heart Rate > 60 bpm )	immediately after delivery
assessment of the need of using additional uterotonic	administration additional drug for the treatment of PPH	immediately after delivery
assessment of the need of using additional uterotonic	administration additional drug for the treatment of PPH	two hours after delivery
assessment the need for the blood transfusions	Hb <7 g/dL	two days 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	immediately after
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	two hours after
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)	two days after delivery

Collaborators and Investigators

• Sponsor: Azienda U.S.L. 1 di Massa e Carrara

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimated): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: PPH; TXA
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Reproductive Control Agents; Oxytocics; Oxytocin; Tranexamic Acid
• Other Study ID Numbers: Azenda USLToscana Nord Ovest

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No