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

NCT02775773 | Completed Phase 3 DMC

• 1 other identifier: Azenda USLToscana Nord Ovest
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Partum Haemorrhage

Keywords

TXA; PPH

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• assessment of the number of hemodynamic changes

  two hours after delivery

• assessment of the number of hemodynamic changes

  immediately after delivery

• assessment of the need of using additional uterotonic

  immediately after delivery

• assessment of the need of using additional uterotonic

  two hours after delivery

• assessment the need for surgical manoeuvres for the bleeding control

  immediately after

Study Arms (2)

arm A (TXA)

EXPERIMENTAL

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

Drug: Tranexamic Acid

arm B (OXY)

ACTIVE COMPARATOR

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

Drug: Oxytocin

Interventions

Tranexamic Acid DRUG

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

Also known as: TXA

arm A (TXA)

Oxytocin DRUG

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

Also known as: OXY

arm B (OXY)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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 )

Sponsors & Collaborators

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

Study Sites (1)

Department of Ostetricia e Ginecologia-Ospedale delle Apuane

Massa, MS, 54100, Italy

Location

Related Publications (1)

• 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.

  PMID: 38873634 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 18, 2016
• Study Start: January 30, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 8, 2024

Record last verified: 2019-01

Locations

IT (1)