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Prophylactic Tranexamic Acid Use After Vaginal Delivery

NCT ID: NCT05429580

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-02-28

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.

Conditions

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Postpartum Hemorrhage Vaginal Delivery Prophylactic Tranexamic Acid Use

Keywords

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tranexamic acid vaginal delivery postpartum hemorrhage active management of vaginal delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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postpartum bleeding risks as low-risk

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.

Group Type OTHER

Tranexamic acid

Intervention Type DRUG

given intravenous tranexamic acid

5% Dextrose

Intervention Type OTHER

given placebo.

postpartum bleeding risks as high-risk

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.

Group Type OTHER

Tranexamic acid

Intervention Type DRUG

given intravenous tranexamic acid

5% Dextrose

Intervention Type OTHER

given placebo.

Interventions

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Tranexamic acid

given intravenous tranexamic acid

Intervention Type DRUG

5% Dextrose

given placebo.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role collaborator

Sanliurfa Mehmet Akif Inan Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nefise Nazlı YENIGUL

Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nefise Nazlı YENIGUL

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2011-KAEK-25 2021/07-22

Identifier Type: -

Identifier Source: org_study_id