Pregnancy and Fibrin Clot Properties

Jagiellonian University

Status: Enrolling

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

Treatments: Diagnostic Test: analysis of fibrin clot properties and thrombin generation

Study type: Observational

Funder types: Other

Identifiers

NCT07275476

1072.6120.23.2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

100 participants in 2 patient groups

Healthy pregnant women

Description:

Determination of fibrin clot properties and thrombin generation

Treatment:

Diagnostic Test: analysis of fibrin clot properties and thrombin generation

Pregnant women with hypertensive disorders during pregnancy

Description:

Determination of fibrin clot properties and thrombin generation

Treatment:

Diagnostic Test: analysis of fibrin clot properties and thrombin generation