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Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH (TRANOXY2015)

NCT02503319 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-02-08

No results posted yet for this study

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.

This is a open-trial randomized, longitudinal, controlled that including 486 subjects .

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Tranexamic Acid

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

DRUG

Oxytocin

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

Sponsors & Collaborators

  • Dr.Antonio Franco Ragusa

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Antonio Ragusa, Dr · Azienda USL1 di Massa e Carrara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02503319 on ClinicalTrials.gov