NCT05429580

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Postpartum Hemorrhage
• Vaginal Delivery
• Prophylactic Tranexamic Acid Use

Interventions

Type	Name	Description
DRUG	Tranexamic acid	given intravenous tranexamic acid
OTHER	5% Dextrose	given placebo.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2022-06-23
• Last updated: 2023-12-04

Locations

1 site across 1 country: Turkey (Türkiye)