Pregnancy and Fibrin Clot Properties

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07275476

Enrollment

100

Registered

2025-12-10

Start date

2025-11-28

Completion date

2027-12-31

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

fibrinolysis, fibrin clot, thrombin generation

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTanalysis of fibrin clot properties and thrombin generation

determination of fibrin clot properties and thrombin generation

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Fibrin clot phenotype	12 months	Fibrin clot phenotype

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026