Prophylactic Tranexamic Acid Use After Vaginal Delivery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postpartum Hemorrhage, Vaginal Delivery, Prophylactic Tranexamic Acid Use

Intervention / Treatment
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* Drug: Tranexamic acid
* Other: 5% Dextrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: postpartum bleeding risks as low-risk<br>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. | Drug: Tranexamic acid<br>* given intravenous tranexamic acid<br>Other: 5% Dextrose<br>* given placebo.<br>|
| Other: postpartum bleeding risks as high-risk<br>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. | Drug: Tranexamic acid<br>* given intravenous tranexamic acid<br>Other: 5% Dextrose<br>* given placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, vaginal delivery, postpartum hemorrhage, active management of vaginal delivery