Skip to main content
OpenTrials
Completed

NCT Number: NCT05429580

Prophylactic Tranexamic Acid Use After Vaginal Delivery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Prophylactic Tranexamic Acid Use Puerperal Disorders Urogenital Diseases Uterine Hemorrhage Vaginal Delivery

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

given intravenous tranexamic acid

5% dextrose

Other

given placebo.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Collaborators

  • Sisli Hamidiye Etfal Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2022
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.