A population-based cohort to evaluate drug safety during pregnancy (PREGVAL): rationale, design, and baseline characteristics.

ABSTRACT: The main aim of the PREGVAL cohort is to evaluate and monitor the in-utero safety of medication administered to pregnant women, as usually this population is excluded from clinical trials assessing drugs. 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,

SUBMITTER: Sanchez-Saez F 

PROVIDER: S-EPMC12304015 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature