Tranexamic Acid for Postpartum Vaginal Laceration Hemorrhage

NCT07094399 | Completed

• 1 other identifier: HRÜ/24.20.49
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

The necessary information was provided to the patients included in the study and their written consent was obtained.

Conditions

Postpartum Hemorrhage; Vaginal Lacerations

Keywords

Postpartum hemorrhage; vaginal laceration; tranexamic acid; topical administration; intravenous administration.

Outcome Measures

Primary Outcomes (1)

• Total Postpartum Blood Loss

  The total amount of postpartum blood loss within the first 3 hours after delivery, measured using the gravimetric method by weighing blood-soaked pads. The difference between the wet and dry weight of the pads was assumed to be the amount of blood loss, with 1 gram of weight gain considered equivalent to 1 ml of blood loss.

  Within the first 3 hours after delivery

Secondary Outcomes (1)

• Number of Pads Used

  First 3 hours postpartum

Other Outcomes (6)

• Change in Hemoglobin (Hb) Levels

  Before delivery (within 1 hour before delivery) and at 3 hours postpartum.

• INR Values

  Before delivery and at 3 hours postpartum

• Change in Hematocrit (Hct) Levels

  Time Frame: Before delivery (within 1 hour before delivery) and at 3 hours postpartum. Unit of Measure: % (percentage).

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: MALE
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

161 women aged 20-35 years who had spontaneous vaginal deliveries.

You may qualify if:

• Vaginal delivery without episiotomy
• Presence of superficial vaginal lacerations
• Postpartum blood loss not exceeding 500 ml
• Age between 20 and 35 years
• Informed consent obtained

You may not qualify if:

• Cesarean delivery
• Episiotomy or vaginal lacerations requiring suturing
• Postpartum bleeding exceeding 500 ml
• Pre-existing coagulation disorders
• Tranexamic acid allergy

Sponsors & Collaborators

• Harran University: lead
• Esra Söylemez, MD (Mardin Education and Research Hospital): collaborator
• Emre Uysal, MD (Yusufeli State Hospital): collaborator

Study Sites (1)

Harran University

Sanliurfa, Şanliurfa, 63200, Turkey (Türkiye)

Location

Related Publications (1)

• Tammo O, Uysal E. Effectiveness of tranexamic acid in intervening postpartum vaginal lacerations. BMC Pregnancy Childbirth. 2025 Dec 16. doi: 10.1186/s12884-025-08584-y. Online ahead of print.

  PMID: 41398944 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

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

Study Officials

• ömer tammo

  omertammo@harran.edu.tr

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: July 30, 2025
• Study Start: January 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

TU (1)