Prophylactic Tranexamic Acid Use After Vaginal Delivery

NCT05429580 | Completed

• 1 other identifier: 2011-KAEK-25 2021/07-22
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage; Vaginal Delivery; Prophylactic Tranexamic Acid Use

Keywords

tranexamic acid; vaginal delivery; postpartum hemorrhage; active management of vaginal delivery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale

  6 months

Study Arms (2)

postpartum bleeding risks as low-risk

OTHER

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; Other: 5% Dextrose

postpartum bleeding risks as high-risk

OTHER

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; Other: 5% Dextrose

Interventions

Tranexamic acid DRUG

given intravenous tranexamic acid

postpartum bleeding risks as high-risk; postpartum bleeding risks as low-risk

5% Dextrose OTHER

given placebo.

postpartum bleeding risks as high-risk; postpartum bleeding risks as low-risk

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• singleton pregnant women
• woman between the ages of 18-45 years
• woman who gave birth at 34 weeks and above

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead
• Sisli Hamidiye Etfal Training and Research Hospital: collaborator

Study Sites (1)

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid; Glucose

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: June 23, 2022
• Study Start: September 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

TU (1)