Prophylactic Tranexamic Acid Use After Vaginal Delivery

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05429580
• Other study ID #: 2011-KAEK-25 2021/07-22
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: December 2023
• Source: Sanliurfa Mehmet Akif Inan Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Vaginal Delivery

Intervention

Drug:
• Tranexamic acid
given intravenous tranexamic acid

Other:
• 5% Dextrose
given placebo.

Locations

Country	Name	City	State
Turkey	Nefise Nazli YENIGUL	Bursa

Sponsors (2)

Lead Sponsor	Collaborator
Sanliurfa Mehmet Akif Inan Education and Research Hospital	Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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