Pregnancy and Fibrin Clot Properties

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-28

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women with hypertensive disorders during pregnancy

Determination of fibrin clot properties and thrombin generation

analysis of fibrin clot properties and thrombin generation

Intervention Type DIAGNOSTIC_TEST

determination of fibrin clot properties and thrombin generation

Healthy pregnant women

Determination of fibrin clot properties and thrombin generation

analysis of fibrin clot properties and thrombin generation

Intervention Type DIAGNOSTIC_TEST

determination of fibrin clot properties and thrombin generation

Interventions

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analysis of fibrin clot properties and thrombin generation

determination of fibrin clot properties and thrombin generation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes