The Assessment of Fibrin Clot Phenotype and Thrombin Generation in Women After Urogynecological Surgeries.

December 8, 2025 updated by: Magdalena Piróg, MD, Jagiellonian University

Fibrin Clot Properties and Thrombin Generation in Women After Urogynecological Surgery.

Determination of fibrin clot properties along with thrombin generation in women after urigynecological surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Fibrin clot permeability and susceptibility to lysis along with thrombin generation

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Małopolska
      • Krakow, Małopolska, Poland, 31-501
        • Recruiting
        • Gynecological Endocrinology Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women with diagnosed uterine prolapse or urine incontinence after failure of pharmacotherapy.

Description

Inclusion Criteria:

  • Age 18-70
  • treatment failure (pharmacotherapy) due to uterine prolapse or urine incontinence

Exclusion Criteria:

  • prolonged thromboprophylaxis
  • planned surgery other than due to urine incontinence/uterine prolapse
  • acquired or congenital thrombophilia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with urine incontinence/ uterine prolapse
Healthy women with urine incontinence/ uterine prolapse qualified for urogynecological surgery
Diagnostic test: determination of fibrin clot properties
Determination of fibre clot properties and thrombin generation in women with uterine prolapse/ urine incontinence before and after urogynecological surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fibrin clot phenotype
Time Frame: December 2025 till May 2026
fibrin clot permeability and susceptibility to lysis
December 2025 till May 2026
Thrombin generation
Time Frame: December 2025 till May 2026
Endogenous thrombin generation
December 2025 till May 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.315.2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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