Venous Thromboembolism Risk associated with Hormonal Contraceptives
Conditions
Brief summary
The normalized activated protein C sensitivity ratio (nAPCsr), determined by calibrated automated thrombography (CAT) assay, evaluated as the quantifiable difference in group means (expressed as absolute and percentage differences with 95% confidence intervals) between each hormonal contraceptive (HC) user subgroup and the healthy non-user control group.
Detailed description
Evaluation of individual thrombin generation parameters, standard coagulation screening tests, routine laboratory parameters, and prothrombotic markers. Secondary outcomes also encompass markers of endothelial activation, fibrinolytic capacity, inflammatory cytokines/chemokines, and inherited thrombophilia screening. Furthermore, secondary analyses include the quantitative evaluation of the influence of modifiable risk factors on hemostatic balance and thrombosis risk across the study cohorts.
Interventions
DRUGLEVONORGESTREL
DRUGDESOGESTREL
DRUGTri-Regol bevont tabletta
DRUGDROSPIRENONE
DRUGESTETROL
DRUGETHINYLESTRADIOL
Sponsors
University Of Debrecen
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The normalized activated protein C sensitivity ratio (nAPCsr), determined by calibrated automated thrombography (CAT) assay, evaluated as the quantifiable difference in group means (expressed as absolute and percentage differences with 95% confidence intervals) between each hormonal contraceptive (HC) user subgroup and the healthy non-user control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of individual thrombin generation parameters, standard coagulation screening tests, routine laboratory parameters, and prothrombotic markers. Secondary outcomes also encompass markers of endothelial activation, fibrinolytic capacity, inflammatory cytokines/chemokines, and inherited thrombophilia screening. Furthermore, secondary analyses include the quantitative evaluation of the influence of modifiable risk factors on hemostatic balance and thrombosis risk across the study cohorts. | — |
Outcome results
None listed