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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05429580
Other study ID # 2011-KAEK-25 2021/07-22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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