Pregnancy and Fibrin Clot Properties

Fibrin Clot Properties and Thrombin Generation in Pregnancy Women With and Without Obstetric Complications.

1. The structure of fibrin clot and thrombin generation may vary between trimesters of pregnancy.
2. Unfavorably altered fibrin clot properties along with enhanced thrombin generation may lead to the development of complications during pregnancy such as TE and hypertensive disorders.
3. The application of machine learning techniques may help to identify previously undetected phenotypes with increased risk of TE and hypertensive disorders during pregnancy.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Fibrin Blood Clot; Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode
• Intervention / Treatment: Diagnostic test: analysis of fibrin clot properties and thrombin generation

Detailed Description

Taken together, the integration of both fibrin clot properties and thrombin generation markers in pregnant women using modern science techniques may reveal new mechanisms explaining the relationship between altered fibrin clot properties and certain pregnancy complications. Moreover, it may help to identify new clot phenotypes of potential clinical significance, indicating prothrombotic risk or elevated chance of development of hypertensive disorders during pregnancy.

Specific working hypotheses:

1. The structure of fibrin clot and thrombin generation may vary between trimesters of pregnancy.
2. Unfavorably altered fibrin clot properties along with enhanced thrombin generation may lead to the development of complications during pregnancy such as TE and hypertensive disorders.
3. The application of machine learning techniques may help to identify previously undetected phenotypes with increased risk of TE and hypertensive disorders during pregnancy.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Poland
  • Małopolska
    • Krakow, Małopolska, Poland, 31-501
      • Recruiting
      • Gynecological Endocrinology Department
      • Contact: Magdalena Piróg, MD, PhD; Phone Number: +48 +48; Email: magda.m.pulka@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Two groups:

1. Healthy pregnant women
2. Pregnant women with hypertensive disorders during pregnancy

Description

Inclusion Criteria:

I. age 18-40 years; II. natural conception (without assisted reproductive techniques).

Exclusion Criteria:

I. use of hormonal therapy (i.e., oral contraceptives, progestogens) within 3 months before or during pregnancy; II. use of anticoagulants oral/subcutaneous within 3 months before or during pregnancy; III. increased risk factors of VTE (i.e., obesity - body mass index >30 kg/m2; smoking) or history of VTE; IV. Concomitant diseases, i.e: severe hypertension, diabetes mellitus, autoimmune diseases (i.e., systemic lupus erythematosus, antiphospholipid syndrome); V. congenital or acquired thrombophilia (i.e., mutation factor V Leiden, prothrombin mutation).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy pregnant women; Determination of fibrin clot properties and thrombin generation	Diagnostic test: analysis of fibrin clot properties and thrombin generation; determination of fibrin clot properties and thrombin generation
Pregnant women with hypertensive disorders during pregnancy; Determination of fibrin clot properties and thrombin generation	Diagnostic test: analysis of fibrin clot properties and thrombin generation; determination of fibrin clot properties and thrombin generation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibrin clot phenotype	Fibrin clot phenotype	12 months

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: thrombin generation; fibrinolysis; fibrin clot
• Other Study ID Numbers: 1072.6120.23.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No