2026-04-14T03:38:35Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/119012025-10-24T10:16:27Zcom_2072_378070com_2072_378040com_2072_378068col_2072_378092col_2072_378090

00925njm 22002777a 4500 dc Bellas, Lucía author Giner-Soriano, Maria author Prats Uribe, Albert author Vedia Urgell, Cristina author Agustí, Antònia author Camacho-Arteaga, Lina author Aguilera, Cristina author 2024-09-05T08:22:44Z 2024-09-05T08:22:44Z 2024-08-12 Àcid valproic; Resultats de l'embaràs; Registres electrònics de salut Ácido valproico; Resultados del embarazo; Registros médicos electrónicos Valproic acid (VPA); Pregnancy outcomes; electronic health records (EHR) Objectives To characterise the exposure to valproate within a cohort of pregnant women using electronic health records (EHRs) from Catalonia (System for the Development of Research in Primary Care, SIDIAP). Design Drug-utilisation cohort study covering the period from January 2011 to June 2020. The study included pregnancy episodes of women from Catalonia identified by the algorithm. Setting Data were sourced from SIDIAP, a comprehensive EHR repository that includes information from various data sources: recorded prescriptions (both hospital and primary care), diagnoses and sociodemographic characteristics identified by primary care physicians, and sexual and reproductive health data from ASSIR (used by gynaecologists and midwives). Participants Women aged 12–50 with at least one pregnancy episode occurred during January 2011–June 2020 and at least a prescription of valproate during pregnancy. Primary and secondary outcomes Primary outcomes included valproate exposure, measured through prevalence and cumulative incidence in pregnancy episodes and by trimester. The impact of regulatory measures (risk mitigation measures, RMMs) was assessed, and prescriptions over time were analysed using interrupted time series analysis. Secondary outcomes included health issues, pregnancy outcomes, smoking habits and socioeconomic characteristics. Results A total of 99 605 pregnancies were identified, with at least 3.03‰ (95% CI 2.69‰ to 3.39‰) exposed to valproate at some point (302 pregnancies, 276 women). The median pregnancy duration was 38.30 weeks (IQR 12.6–40.1), and the median age at pregnancy was 32.37 years (IQR 27.20–36.56). Epilepsy was the most frequent health issue. The prevalence and cumulative incidence of valproate prescriptions decreased during pregnancy and increased postpregnancy. The RMMs implemented in 2014 led to a reduction in monthly valproate prescriptions during pregnancy in this cohort. Conclusions The study highlights the decline in valproate prescriptions during pregnancy due to RMMs and underscores the need for standardised methodologies in future studies to ensure the safety of pregnant patients and optimise scientific evidence. This study received funding from the 8th call for SIDIAP grants, 20182019, expedient number 4R18/188; and from Health Department of the Generalitat de Catalunya, in the call corresponding to 2021 for the granting of funding of the Strategic Plan for Research and Innovation in Health (PERIS) 2021–2024, modality Research Projects in Primary Care, expedient number SLT/21/000068 (MG- S). http://hdl.handle.net/11351/11901 Àcid valproic Anticonvulsius Embaràs - Complicacions CHEMICALS AND DRUGS::Organic Chemicals::Carboxylic Acids::Acids, Acyclic::Valerates::Pentanoic Acids::Valproic Acid Other subheadings::Other subheadings::/therapeutic use CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Central Nervous System Agents::Anticonvulsants Other subheadings::Other subheadings::Other subheadings::/adverse effects PUBLIC HEALTH::Environmental Health::Health::Environmental Illness::Pregnancy Complications Other subheadings::Other subheadings::Other subheadings::/epidemiology COMPUESTOS QUÍMICOS Y DROGAS::compuestos orgánicos::ácidos carboxílicos::ácidos acíclicos::valeratos::ácidos pentanoicos::ácido valproico Otros calificadores::Otros calificadores::/uso terapéutico COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::fármacos del sistema nervioso central::anticonvulsivantes Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos SALUD PÚBLICA::salud ambiental::salud::enfermedad ambiental::complicaciones del embarazo Otros calificadores::Otros calificadores::Otros calificadores::/epidemiología Women’s health in focus: Real-world data on valproate prescriptions during pregnancy – a cohort study in Catalonia (Spain)