Contraception, Venous Thromboembolism
Conditions
Brief summary
This prospective cohort evaluates the longitudinal profile of hemostatic biomarkers during the first 3 months after having stopped a combined oral contraceptive.
Detailed description
Women using a combined oral contraceptive (COC) and who have decided to stop it or switch it to a non-estrogenic contraceptive are included. At baseline, before the COC is stopped, and at multiple time points during the 3 months of follow-up, blood will be drawn to evaluate the hemostatic profile. Findings are compared with a control group of women without an estrogenic contraceptive, who are also followed for 3 months.
Interventions
OTHERTests of biological hemostatic profile associated with contraceptives
Tests of biological hemostatic profile associated with contraceptives will be done before and after having stopped an estrogenic contraceptive (group 1) and during the non-use of an estrogenic contraceptive (group 2)
Sponsors
University Hospital, Geneva
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Inclusion criteria
* women * 18-50 years * current use (for at least 3 months) of an estrogenic contraceptive with the decision to stop it or replace it with a non-estrogenic contraceptive (estrogen group) * no current use of an estrogenic contraceptive (control group)
Exclusion criteria
* personal history of VTE * known thrombophilia * recent medical event (hospitalization, surgery, cancer) * pregnancy, post-partum period, current breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in normalized APC sensitivity ratio | Three months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Endogenous Thrombin Potential (Thrombin Generation Assay) | Three months | — |
| Change in concentrations of sex hormone-binding globulin | Three months | — |
| Change in fibrinolysis assay | Three months | — |
| Change in individual coagulation factors | Three months | The following coagulation factors will be assessed: fibrinogen, protein C, protein S, antithrombin, factor VIII |
| Contraception-related satisfaction | Three months | Satisfaction will be estimated by the use of the Ortho Birth Control Satisfaction Assessment Tool questionnaire. |
Countries
Switzerland
Outcome results
None listed