Prophylactic Tranexamic Acid Use After Vaginal Delivery

Not Applicable

Completed

• Conditions: Prophylactic Tranexamic Acid Use; Postpartum Hemorrhage; Vaginal Delivery
• Interventions: Drug: Tranexamic acid; Other: 5% Dextrose

• Registration Number: NCT05429580
• Lead Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital

Brief 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.

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Study First Submitted: 2022-06-18
• Study First Submitted QC: 2022-06-18
• Study First Posted: 2022-06-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 480

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
postpartum bleeding risks as high-risk	5% Dextrose	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.
postpartum bleeding risks as low-risk	5% Dextrose	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.
postpartum bleeding risks as low-risk	Tranexamic acid	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.
postpartum bleeding risks as high-risk	Tranexamic acid	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale	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.

Trial Locations

Locations (1)

Nefise Nazlı YENIGUL; 🇹🇷 Bursa, Turkey