{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T02:00:31Z","timestamp":1760148031137,"version":"build-2065373602"},"reference-count":44,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2023,3,27]],"date-time":"2023-03-27T00:00:00Z","timestamp":1679875200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JPM"],"abstract":"<jats:p>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\u2019s eligibility, mitigate thromboembolic risk, and assure legal protection to healthcare providers. In this systematic review in particular, we refer to the Italian medical\u2013legal 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.<\/jats:p>","DOI":"10.3390\/jpm13040584","type":"journal-article","created":{"date-parts":[[2023,3,27]],"date-time":"2023-03-27T06:46:19Z","timestamp":1679899579000},"page":"584","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A Multi-Institutional Informed Consent Proposal as a Prevention Tool for Combined Oral Contraceptive Intake and Thrombotic Risk"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4771-6287","authenticated-orcid":false,"given":"Marina","family":"Vinciguerra","sequence":"first","affiliation":[{"name":"Unit of Obstetrics and Gynaecology, Department of Biomedical Sciences and Human Oncology, 70132 Bari, Italy"},{"name":"Department of Obstetrics and Gynaecology, \u201cSanta Caterina Novella Hospital\u201d, 73013 Galatina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1287-4285","authenticated-orcid":false,"given":"Eliano","family":"Cascardi","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, University of Turin, 10124 Turin, Italy"},{"name":"Pathology Unit, FPO-IRCCS Candiolo Cancer Institute, Str. Provinciale 142 km 3.95, 10060 Candiolo, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7732-2003","authenticated-orcid":false,"given":"Bruno","family":"Lamanna","sequence":"additional","affiliation":[{"name":"Unit of Obstetrics and Gynaecology, Department of Biomedical Sciences and Human Oncology, 70132 Bari, Italy"},{"name":"Fetal Medicine Research Institute, King\u2019s College Hospital, London SE5 9RS, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1058-7269","authenticated-orcid":false,"given":"Maricla","family":"Marrone","sequence":"additional","affiliation":[{"name":"Section of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari \u201cAldo Moro\u201d, 70121 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7450-3282","authenticated-orcid":false,"given":"Fortunato","family":"Pititto","sequence":"additional","affiliation":[{"name":"Section of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari \u201cAldo Moro\u201d, 70121 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1332-8278","authenticated-orcid":false,"given":"Enrica","family":"Macorano","sequence":"additional","affiliation":[{"name":"Section of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari \u201cAldo Moro\u201d, 70121 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7698-8823","authenticated-orcid":false,"given":"Romualdo","family":"Sciorio","sequence":"additional","affiliation":[{"name":"EFREC (Edinburgh Assisted Conception Programme), \u201cRoyal Infirmary of Edinburgh\u201d, Edinburgh EH16 4SA, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5061-8007","authenticated-orcid":false,"given":"Giorgio Maria","family":"Baldini","sequence":"additional","affiliation":[{"name":"Mom\u00f2 Fertilife Clinic, 76011 Bisceglie, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio","family":"Malvasi","sequence":"additional","affiliation":[{"name":"Unit of Obstetrics and Gynaecology, Department of Biomedical Sciences and Human Oncology, 70132 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8758-1415","authenticated-orcid":false,"given":"Andrea","family":"Ballini","sequence":"additional","affiliation":[{"name":"Department of Precision Medicine, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0325-4316","authenticated-orcid":false,"given":"Gerardo","family":"Cazzato","sequence":"additional","affiliation":[{"name":"Department of Precision and Regenerative Medicine and Jonic Area, University of Bari \u201cAldo Moro\u201d, 70121 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9862-1619","authenticated-orcid":false,"given":"Antonella","family":"Vimercati","sequence":"additional","affiliation":[{"name":"Department of Precision and Regenerative Medicine and Jonic Area, University of Bari \u201cAldo Moro\u201d, 70121 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Senthil","family":"Kumaran","sequence":"additional","affiliation":[{"name":"Department of Forensic Medicine and Toxicology, All India Institute of Medical Sciences, Mangalagiri 522503, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2390-4582","authenticated-orcid":false,"given":"Ettore","family":"Cicinelli","sequence":"additional","affiliation":[{"name":"Unit of Obstetrics and Gynaecology, Department of Biomedical Sciences and Human Oncology, 70132 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2717-2489","authenticated-orcid":false,"given":"Salvatore","family":"Scacco","sequence":"additional","affiliation":[{"name":"Department of Basic Medical Sciences and Neurosciences, University of Bari \u201cAldo Moro\u201d, 70121 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3522-4648","authenticated-orcid":false,"given":"Miriam","family":"Dellino","sequence":"additional","affiliation":[{"name":"Unit of Obstetrics and Gynaecology, Department of Biomedical Sciences and Human Oncology, 70132 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,3,27]]},"reference":[{"key":"ref_1","first-page":"59","article-title":"Failure rates of contraceptive methods","volume":"1","author":"McLure","year":"1981","journal-title":"Fam. 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