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Review
. 2023 Mar 27;13(4):584.
doi: 10.3390/jpm13040584.

A Multi-Institutional Informed Consent Proposal as a Prevention Tool for Combined Oral Contraceptive Intake and Thrombotic Risk

Marina Vinciguerra  1   2 , Eliano Cascardi  3   4 , Bruno Lamanna  1   5 , Maricla Marrone  6 , Fortunato Pititto  6 , Enrica Macorano  6 , Romualdo Sciorio  7 , Giorgio Maria Baldini  8 , Antonio Malvasi  1 , Andrea Ballini  9 , Gerardo Cazzato  10 , Antonella Vimercati  10 , Senthil Kumaran  11 , Ettore Cicinelli  1 , Salvatore Scacco  12 , Miriam Dellino  1
Affiliations
Review

A Multi-Institutional Informed Consent Proposal as a Prevention Tool for Combined Oral Contraceptive Intake and Thrombotic Risk

Marina Vinciguerra et al. J Pers Med. .

Abstract

Combined oral contraceptives (COC), are among the most widely used contraceptive methods in the world today. Despite the different changes in terms of estrogen/progestogen combinations and dosages, the thromboembolic risk for a woman who takes combined oral contraceptives persists to date.

Methods: The review of relevant literature and international guidelines on prescription of combined oral contraceptives made it possible to create a proposal for informed consent to be used for prescribing.

Results: The several sections of our consent proposal were designed according to a rationale in order to cover all the aspects presented by worldwide guidelines: how to take, adverse effects, advertisements, extra-contraceptive benefits and effects, a checklist for condition at risk of thromboembolism, the signature of the woman.

Conclusions: An informed consent to standardize combined oral contraceptives prescription can improve women's eligibility, mitigate thromboembolic risk, and assure legal protection to healthcare providers. In this systematic review in particular, we refer to the Italian medical-legal scenario, to which our group of researchers belongs. However, the model proposed was designed in the respect of main healthcare organization guidelines, and it could be easily used by any center in the world.

Keywords: contraceptive informed consent; oral contraceptive; thrombosis risk; venous thromboembolism.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Contraceptive methods and thrombosis risk: The pyramid on the left (A) groups the different contraceptive systems, including physiological conditions such as pregnancy, classifying them according to the corresponding risk of thrombotic events (highlighted by the change in color, from yellow to red); the pyramid on the right (B) shows the various progestin components of the combined oral contraceptives available on the market classified according to their risk of thrombotic events.
Figure 2
Figure 2
PRISMA flowchart diagram of the inclusion process.
See this image and copyright information in PMC

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