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Prophylactic Tranexamic Acid Use After Vaginal Delivery

Primary Purpose

Postpartum Hemorrhage, Vaginal Delivery, Prophylactic Tranexamic Acid Use

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tranexamic acid
5% Dextrose
Sponsored by
Sanliurfa Mehmet Akif Inan Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring tranexamic acid, vaginal delivery, postpartum hemorrhage, active management of vaginal delivery

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Nefise Nazlı YENIGUL

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

postpartum bleeding risks as low-risk

postpartum bleeding risks as high-risk

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 18, 2022
Last Updated
June 18, 2022
Sponsor
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Collaborators
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05429580
Brief Title
Prophylactic Tranexamic Acid Use After Vaginal Delivery
Official Title
Efficacy of Prophylactic Tranexamic Acid Use After Vaginal Delivery According to Postpartum Hemorrhage Risk: Randomised, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Collaborators
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Vaginal Delivery, Prophylactic Tranexamic Acid Use
Keywords
tranexamic acid, vaginal delivery, postpartum hemorrhage, active management of vaginal delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
postpartum bleeding risks as low-risk
Arm Type
Other
Arm Description
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.
Arm Title
postpartum bleeding risks as high-risk
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
given intravenous tranexamic acid
Intervention Type
Other
Intervention Name(s)
5% Dextrose
Intervention Description
given placebo.
Primary Outcome Measure Information:
Title
The loss of blood at the 3rd and 4th stages of labor
Description
It was calculated by weighing the blood collected with the help of collecting bag and using the estimated blood loss formula.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Nefise Nazlı YENIGUL
City
Bursa
ZIP/Postal Code
16110
Country
Turkey

12. IPD Sharing Statement

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Prophylactic Tranexamic Acid Use After Vaginal Delivery

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