Fibrin clot and thrombin changes during pregnancy
Official title: Fibrin Clot Properties and Thrombin Generation in Pregnancy Women With and Without Obstetric Complications.
Run by Jagiellonian University · NCT07275476 · Data updated 2026-11-12
This project will test whether fibrin clot structure and thrombin generation change across pregnancy and whether those changes predict blood-clot or high-blood-pressure complications in pregnant women.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Jagiellonian University Academic / other |
| Locations | 1 site (Krakow, Małopolska) |
| Status | Recruiting |
| Started | November 28, 2025 |
| Main results expected | January 2026 |
| Study ends | December 2027 |
| Registry record updated | December 10, 2025 |
| Trial ID | NCT07275476 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women aged 18–40 with natural conception who are not obese, not smoking, not taking anticoagulants or recent hormonal therapy, and without prior VTE, thrombophilia, or major comorbidities.
✕Probably not a fit
Women who used assisted reproductive techniques, have congenital or acquired thrombophilia, prior VTE, obesity, active autoimmune disease, or recent anticoagulant or hormonal therapy are excluded and would not be eligible to benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project will collect blood samples from pregnant women at different trimesters and after delivery to measure fibrin clot architecture and thrombin generation markers. Laboratory assays will quantify clot properties and thrombin generation, and the dataset will be analyzed using machine-learning to identify distinct clot phenotypes. The protocol excludes women with known thrombophilia, prior VTE, obesity, smoking, assisted reproduction, anticoagulant use, or major comorbidities to focus on natural, lower-risk pregnancies. The aim is to link specific laboratory clot features with clinical outcomes such as thromboembolism and hypertensive disorders of pregnancy.
Why it matters
Potential benefit: If successful, the findings could help identify pregnant women at higher risk of thromboembolic or hypertensive complications so clinicians can target monitoring or preventive measures.
How similar studies have gone: Previous research has linked altered fibrin clot properties and increased thrombin generation to thrombotic risk, but combining these markers with machine-learning specifically in pregnancy is relatively new and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
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Gynecological Endocrinology Department
Krakow, Małopolska, Poland Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.