Pregnancy and Fibrin Clot Properties
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: analysis of fibrin clot properties and thrombin generation.
- Who it may be relevant to
- Registry conditions: Fibrin Blood Clot, Pregnancy, Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fibrin Clot Properties and Thrombin Generation in Pregnancy Women With and Without Obstetric Complications.
Overview
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 test analysis of fibrin clot properties and thrombin generation
determination of fibrin clot properties and thrombin generation
Primary outcome measures
- Fibrin clot phenotype [Time frame: 12 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Poland · 1 center
- Gynecological Endocrinology Department — Krakow
Identifiers
NCT: NCT07275476 · 1072.6120.23.2025