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NCT Number: NCT07275476

Pregnancy and Fibrin Clot Properties

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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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Gynecological Endocrinology Department

Krakow, Małopolska, 31-501, Poland

Location status: Recruiting

Location contact

Magdalena Piróg, MD, PhD

CONTACT

[email protected]

+48 ext. +48

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

analysis of fibrin clot properties and thrombin generation

Diagnostic Test

determination of fibrin clot properties and thrombin generation

Primary outcomes

  1. Fibrin clot phenotype

    Time frame: 12 months

    Fibrin clot phenotype

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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