Prophylactic Tranexamic Acid Use After Vaginal Delivery

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage; Vaginal Delivery; Prophylactic Tranexamic Acid Use
• Intervention / Treatment: Drug: Tranexamic acid; Other: 5% Dextrose

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.

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16110
    • Nefise nazlı Yenigül

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Tranexamic acid; given intravenous tranexamic acid; Other: 5% Dextrose; 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.	Drug: Tranexamic acid; given intravenous tranexamic acid; Other: 5% Dextrose; given placebo.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale	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.	6 months

Collaborators and Investigators

• Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
• Collaborators: Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: June 18, 2022
• First Submitted That Met QC Criteria: June 18, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: tranexamic acid; postpartum hemorrhage; vaginal delivery; active management of vaginal delivery
• 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; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2011-KAEK-25 2021/07-22

Drug and device information, study documents

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