Prophylactic Tranexamic Acid Use After Vaginal Delivery

Overview

In this study, our aim was to evaluate the effectiveness of prophylactic tranexamic acid use after vaginal delivery in pregnant women aged 18-45 years and 34-42 weeks according to the risk of postpartum hemorrhage.

Full Title of Study: “Efficacy of Prophylactic Tranexamic Acid Use After Vaginal Delivery According to Postpartum Hemorrhage Risk: Randomised, Double-blind, Placebo-controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2022

Detailed Description

It was carried out as a double-blind prospective randomized controlled Phase 4 drug study with 480 singleton pregnant women in Bursa Yüksek İhtisas Training and Research Hospital between September 1, 2021 and February 28, 2022. The patients were divided into two groups as low risk (240 patients) and high risk (240 patients) according to their postpartum hemorrhage risks, and the patients in each group were randomly divided into two groups. Group 1: were given intravenous tranexamic acid and group 2: were given placebo. The blood loss at the 3rd and 4th stages of labor was calculated by weighing the blood collected with the help of a collecting pochette and using the estimated blood loss formula.

Interventions

  • Drug: Tranexamic acid
    • given intravenous tranexamic acid
  • Other: 5% Dextrose
    • given placebo.

Arms, Groups and Cohorts

  • Other: postpartum bleeding risks as low-risk
    • The patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo.
  • Other: postpartum bleeding risks as high-risk
    • The patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo.

Clinical Trial Outcome Measures

Primary Measures

  • The loss of blood at the 3rd and 4th stages of labor
    • Time Frame: 6 month
    • It was calculated by weighing the blood collected with the help of collecting bag and using the estimated blood loss formula.

Secondary Measures

  • The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale
    • Time Frame: 6 months
    • The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale association with atony, need for blood transfusion, need for extra uterotonics, and the gastrointestinal side effects of tranexamic acid such as nausea, vomiting, and diarrhea were evaluated.

Participating in This Clinical Trial

Inclusion Criteria

  • singleton pregnant women – woman between the ages of 18-45 years – woman who gave birth at 34 weeks and above Exclusion Criteria:

  • Pregnancies with less than 1 hour period between hospitalization and delivery – Women with placenta previa, invasion anomaly or diagnosis of abruptio placentae – Women with previous uterine surgery or cesarean section – Women with a history of thromboembolism – women with serious illness

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sanliurfa Mehmet Akif Inan Education and Research Hospital
  • Collaborator
    • Sisli Hamidiye Etfal Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nefise Nazlı YENIGUL, Ph.D. Assistant Professor Department of Obstetrics and Gynecology – Sanliurfa Mehmet Akif Inan Education and Research Hospital

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