Fibrin Blood ClotNCT07275476
Pregnancy and Fibrin Clot Properties
An observational study of Fibrin Blood Clot and Pregnancy, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibrin Blood Clot, Pregnancy, Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode
- What is being tested?
- analysis of fibrin clot properties and thrombin generation
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 28 Nov 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Two groups: 1. Healthy pregnant women 2. Pregnant women with hypertensive disorders during pregnancy
Who may be able to join
- age 18-40 years; II. natural conception (without assisted reproductive techniques).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Gynecological Endocrinology Department
Krakow, Małopolska, 31-501
Magdalena Piróg, MD, PhD, +48 ext. +48, magda.m.pulka@gmail.com
About this study
Official title: Fibrin Clot Properties and Thrombin Generation in Pregnancy Women With and Without Obstetric Complications.
- 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.
Read the 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:
- 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.
- Conditions
- Fibrin Blood Clot, Pregnancy, Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode
- Being tested
- analysis of fibrin clot properties and thrombin generation
- Keywords
- fibrinolysis, fibrin clot, thrombin generation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of fibrin clot properties and thrombin generationDiagnostic test
determination of fibrin clot properties and thrombin generation
| Study group | Role | What they receive |
|---|---|---|
| Healthy pregnant women | Determination of fibrin clot properties and thrombin generation Receives: Diagnostic Test: analysis of fibrin clot properties and thrombin generation | |
| Pregnant women with hypertensive disorders during pregnancy | Determination of fibrin clot properties and thrombin generation Receives: Diagnostic Test: analysis of fibrin clot properties and thrombin generation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrin clot phenotype
Fibrin clot phenotype
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start28 Nov 2025
- Primary completionJan 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrin Blood ClotStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Piróg, MD, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275476
- Sponsor's protocol ID
- 1072.6120.23.2025
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrin Clot Properties and Thrombin Generation in Pregnancy Women With and Without Obstetric Complications.
- ClinicalTrials.gov ID
- NCT07275476
- Acronym / sponsor ID
- 1072.6120.23.2025
- Conditions
- Fibrin Blood Clot, Pregnancy, Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode
- Keywords
- fibrinolysis, fibrin clot, thrombin generation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy pregnant women | – | Diagnostic Test: analysis of fibrin clot properties and thrombin generationDetermination of fibrin clot properties and thrombin generation |
| Pregnant women with hypertensive disorders during pregnancy | – | Diagnostic Test: analysis of fibrin clot properties and thrombin generationDetermination of fibrin clot properties and thrombin generation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Two groups: 1. Healthy pregnant women 2. Pregnant women with hypertensive disorders during pregnancy
Key inclusion criteria (1 listed)
- age 18-40 years; II. natural conception (without assisted reproductive techniques).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analysis of fibrin clot properties and thrombin generationdetermination of fibrin clot properties and thrombin generation | Diagnostic test | Healthy pregnant women, Pregnant women with hypertensive disorders during pregnancy |
Primary outcome
Fibrin clot phenotype
Time frame: 12 months
Fibrin clot phenotype
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrin Blood Clot and Pregnancy, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrin clot phenotype (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.