Pregnancy and Fibrin Clot Properties

NCT07275476 | Recruiting

• 1 other identifier: 1072.6120.23.2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The structure of fibrin clot and thrombin generation may vary between trimesters of pregnancy.
2. 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. 3.The application of machine learning techniques may help to identify previously undetected phenotypes with increased risk of TE and hypertensive disorders during pregnancy.

Conditions

Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode; Pregnancy; Fibrin Blood Clot

Keywords

fibrinolysis; fibrin clot; thrombin generation

Outcome Measures

Primary Outcomes (1)

• Fibrin clot phenotype

  Fibrin clot phenotype

  12 months

Study Arms (2)

Healthy pregnant women

Determination of fibrin clot properties and thrombin generation

Diagnostic Test: analysis 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

Interventions

analysis of fibrin clot properties and thrombin generation DIAGNOSTIC_TEST

determination of fibrin clot properties and thrombin generation

Healthy pregnant women; Pregnant women with hypertensive disorders during pregnancy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Females as they can get pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Gynecological Endocrinology Department

Krakow, Małopolska, 31-501, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be drawn from an antecubital vein with minimal stasis using atraumatic venipuncture at 8 to 10 AM and collected into serum tubes and into tubes with anticoagulants: EDTAand sodium citrate (2.6 ml and 3.2%, respectively, 9:1) (Monovette, all from Sarstedt, Nümbrecht, Germany).

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: November 28, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)