Pregnancy and Fibrin Clot Properties | NCT07275476

Studies
Pregnancy and Fibrin Clot Properties

NCT07275476

Sponsor

Jagiellonian University

Status

Recruiting

Last Update Posted

Dec 10, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

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

Interventions

analysis of fibrin clot properties and thrombin generation

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 28, 2025Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Nov 28, 2025

First Submission Date that Met QC Criteria

Nov 28, 2025

First Posted Date

Dec 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2025

Last Update Posted Date

Dec 10, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Magdalena Piróg, MD, Principal Investigator, Jagiellonian UniversityPrincipal Investigator

Lead Sponsor

Jagiellonian UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy pregnant women		Determination of fibrin clot properties and thrombin generation	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	Diagnostic Test: analysis of fibrin clot properties and thrombin generation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
analysis of fibrin clot properties and thrombin generation	Diagnostic Test	determination of fibrin clot properties and thrombin generation	Healthy pregnant women Pregnant women with hypertensive disorders during pregnancy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Females as they can get pregnant

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Two groups:

Healthy pregnant women
Pregnant women with hypertensive disorders during pregnancy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gynecological Endocrinology Department	Recruiting	Krakow	Małopolska	31-501	Poland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Description

Venous blood samples will be drawn from an antecubital vein with minimal stasis using atraumatic venipuncture at 8 to 10 AM and collected into serum tubes and into tubes with anticoagulants: EDTAand sodium citrate (2.6 ml and 3.2%, respectively, 9:1) (Monovette, all from Sarstedt, Nümbrecht, Germany).