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It is a population-based cohort, comprised by pregnant women and their offspring in the Valencia Region (Spain), between July 1st 2009 and December 31st 2021, which will be followed from 6 months pre-conception until death, loss of coverage or end of study, with over 520.000 pregnancies for the study period. The data source will be the Valencia Integrated Database (VID), which links records at the individual level using a unique personal identification code, with exhaustive data on comorbidities (diabetes, hypertension, etc.) and other clinical variables, sociodemographic variables (age, socio-economic status, risk of social exclusion) and other potential confounders (smoking, alcohol intake). It also provides accurate data on timing of exposure for most livebirths and all of the stillbirths occurred in the region, and partially for spontaneous abortions and elective terminations (due to the availability of gestational age by ultrasound or last menstrual period for these outcomes allowing the calculation of the date of conception) and allows the identification of medications prescription and dispensation data with a very high detail, avoiding the problem of potential exposure misclassification present in many of the existent registries\/cohorts. Regarding outcomes, there is exhaustive and accurate data on pregnancy complications, spontaneous abortions, terminations (in this case, those occurred within the public health system), birth weight, preterm birth, congenital anomalies, and perinatal mortality; as well as the availability of post-natal long-term follow-up. These features make the PREGVAL study one of the largest and most exhaustive cohorts to assess real-world in-utero safety of medications to date.<\/jats:p>","DOI":"10.1007\/s10654-025-01260-7","type":"journal-article","created":{"date-parts":[[2025,6,23]],"date-time":"2025-06-23T04:50:25Z","timestamp":1750654225000},"page":"859-869","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A population-based cohort to evaluate drug safety during pregnancy (PREGVAL): rationale, design, and baseline characteristics"],"prefix":"10.1007","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3011-9884","authenticated-orcid":false,"given":"Francisco","family":"S\u00e1nchez-S\u00e1ez","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7098-4576","authenticated-orcid":false,"given":"Gabriel","family":"Sanf\u00e9lix-Gimeno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8475-8112","authenticated-orcid":false,"given":"Isabel","family":"Hurtado","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4313-3976","authenticated-orcid":false,"given":"An\u00edbal","family":"Garc\u00eda-Sempere","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5838-9333","authenticated-orcid":false,"given":"Mar\u00eda","family":"Garc\u00e9s-S\u00e1nchez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9045-1651","authenticated-orcid":false,"given":"Fran","family":"Llopis-Cardona","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3902-569X","authenticated-orcid":false,"given":"Salvador","family":"Peir\u00f3","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2617-8635","authenticated-orcid":false,"given":"Clara L.","family":"Rodr\u00edguez-Bernal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,6,23]]},"reference":[{"key":"1260_CR1","doi-asserted-by":"publisher","first-page":"e511","DOI":"10.1016\/j.ajog.2011.02.029","volume":"205","author":"AA Mitchell","year":"2011","unstructured":"Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hern\u00e1ndez-D\u00edaz S, et al. 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The project uses pseudo-anonymized data transferred after the corresponding authorization by the Regional Health Authority (Conselleria de Sanidad Universal y Salud P\u00fablica) of the Valencia region that is be responsible for the anonymization and will retain the necessary information for a possible reidentification in the cases provided by law. The project was submitted for approval by the Drug Research Ethics Committee (CEIm) of the University Hospital Clinic of Valencia.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent need was waved by the ethics committee given the nature of the source of data.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"The authors have no relevant financial or non-financial interests to disclose.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interest"}}]}}