Peer-Reviewed Publication
Pharmacoepidemiol Drug Saf2026;35(8):e70438.August 1, 2026Journal Article
Identifying Pregnancies in Population-Based Data Sources: Development and Application of the ConcePTION Pregnancy Algorithm.
Giorgio Limoncella1,2,3, Anna Girardi3, Claudia Bartolini3, Giulia Hyeraci3, Giuseppe Roberto3, Olga Paoletti3, Davide Messina3, Felipe Villalobos4, Carlo Alberto Bisacco4, Jesse van den Berg5, Eline Houben5, Katia Santacà6, Ylenia Ingrasciotta6, Gianluca Trifirò6, Giorgia Pellegrini6, Valentina Ientile7,8, Vjola Hoxhaj9, Carlos Durán9, Judit Riera-Arnau9, Patricia García-Poza10, Mar Martín-Pérez10, Ana Llorente-García10, Lucia Cea-Soriano11, Consuelo Huerta-Álvarez11, Francisco Sánchez-Sáez12,13,14, Gabriel Sanfélix-Gimeno12,13, Clara L Rodríguez-Bernal12,13, Jérémy Jové15, Marie-Agnès Bernard15, Nicolas H Thurin15, Sue Jordan16, Daniel Thayer16, Hywel Turner Evans16, Alex-Ioan Coldea16, Marco Manfrini17, Marleen van Gelder18, Michele Tari19, Romin Pajouheshnia20, Ana Sofia Afonso Maciel21, Maryline Le Noan-Lainé22, Ditte Mølgaard-Nielsen23, Marianne Cunnington24, Caitlin Dodd25, Leonardo Grilli1, Constanza L Andaur Navarro9, Miriam Sturkenboom9, Hedvig Nordeng18, Rosa Gini3
1Department of Statistics, Informatics and Applications "Giuseppe Parenti", University of Florence, Florence, Italy.
2Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
3ARS Toscana, Florence, Italy.
4Fundació Institut Universitari Per a la Recerca a L'atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
5PHARMO Institute for Drug Outcomes Research, Utrecht, the Netherlands.
6Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
7Italian National Institute for Nuclear Physics, Catania, Italy.
8Department of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, Messina, Italy.
9Department of Data Science & Biostatistics, Julius Center, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands.
10Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.
11Department of Public Health and Maternal Child Health, Faculty of Medicine, Complutense University of Madrid.
12Health Services Research and Pharmacoepidemiology Unit, Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Valencia, Spain.
13Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Valencia, Spain.
14Departament of Applied Statistics and Operational Research, and Quality, Universitat Politècnica de València, Valencia, Spain.
15Bordeaux PharmacoEpi, INSERM CIC-P 1401, Université de Bordeaux, Bordeaux, France.
16Faculty of Medicine, Health and Life Science, Swansea University, Wales, UK.
17Department of Medical Sciences, Centre for Clinical and Epidemiological Research, Ferrara University, Italy.
18Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, University of Oslo (UiO), Oslo, Norway.
19Caserta Local Health Unit, Caserta, Italy.
20RTI Health Solutions, Department of Epidemiology, Barcelona, Spain.
21Global Patient Safety, Eli Lilly BV, Utrecht, the Netherlands.
22Global Patient Safety, Eli Lilly, Cork, Ireland.
23Global Patient Safety, Novo Nordisk A/S, Soeborg, Denmark.
24Analysis Group, Inc., London, UK.
25Panalgo, Amsterdam, the Netherlands.
Abstract
PURPOSE: In 2019, the Innovative Medicines Initiative funded the ConcePTION project to enhance monitoring of medication safety in pregnancy and breastfeeding. This paper describes how the ConcePTION Pregnancy Algorithm (PA) identified pregnancies in 10 diverse European electronic healthcare data sources and estimated their duration.
METHODS: Data sources from six European countries were mapped to…
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