Evidence map›Paper›PMID 42571911›Full record

ArticlePharmacoepidemiology and drug safety2026

Identifying Pregnancies in Population-Based Data Sources: Development and Application of the ConcePTION Pregnancy Algorithm.

Giorgio Limoncella, Anna Girardi, Claudia Bartolini, Giulia Hyeraci, Giuseppe Roberto, Olga Paoletti, Davide Messina, Felipe Villalobos, Carlo Alberto Bisacco, Jesse van den Berg and 38 more

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Article in Pharmacoepidemiology and drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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1 · What the graph read from it

What it found

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2 · The registry

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3 · Its place in the literature

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1 citing paper in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

48 authors.

Giorgio LimoncellaDepartment of Statistics, Informatics and Applications "Giuseppe Parenti", University of Florence, Florence, Italy.ORCID https://orcid.org/0009-0008-3200-5654
Anna GirardiARS Toscana, Florence, Italy.
Claudia BartoliniARS Toscana, Florence, Italy.
Giulia HyeraciARS Toscana, Florence, Italy.
Giuseppe RobertoARS Toscana, Florence, Italy.ORCID https://orcid.org/0000-0001-6478-6442
Olga PaolettiARS Toscana, Florence, Italy.
Davide MessinaARS Toscana, Florence, Italy.
Felipe VillalobosFundació Institut Universitari Per a la Recerca a L'atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
Carlo Alberto BisaccoFundació Institut Universitari Per a la Recerca a L'atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
Jesse van den BergPHARMO Institute for Drug Outcomes Research, Utrecht, the Netherlands.
Eline HoubenPHARMO Institute for Drug Outcomes Research, Utrecht, the Netherlands.
Katia SantacàDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Ylenia IngrasciottaDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Gianluca TrifiròDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Giorgia PellegriniDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Valentina IentileItalian National Institute for Nuclear Physics, Catania, Italy.
Vjola HoxhajDepartment of Data Science & Biostatistics, Julius Center, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands.ORCID https://orcid.org/0009-0007-2194-0818
Carlos DuránDepartment of Data Science & Biostatistics, Julius Center, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands.ORCID https://orcid.org/0000-0003-1853-3641
Judit Riera-ArnauDepartment of Data Science & Biostatistics, Julius Center, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands.ORCID https://orcid.org/0000-0001-7591-0218
Patricia García-PozaDivision of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.
Mar Martín-PérezDivision of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.
Ana Llorente-GarcíaDivision of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.
Lucia Cea-SorianoDepartment of Public Health and Maternal Child Health, Faculty of Medicine, Complutense University of Madrid.
Consuelo Huerta-ÁlvarezDepartment of Public Health and Maternal Child Health, Faculty of Medicine, Complutense University of Madrid.
Francisco Sánchez-SáezHealth Services Research and Pharmacoepidemiology Unit, Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Valencia, Spain.
Gabriel Sanfélix-GimenoHealth Services Research and Pharmacoepidemiology Unit, Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Valencia, Spain.
Clara L Rodríguez-BernalHealth Services Research and Pharmacoepidemiology Unit, Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Valencia, Spain.
Jérémy JovéBordeaux PharmacoEpi, INSERM CIC-P 1401, Université de Bordeaux, Bordeaux, France.
Marie-Agnès BernardBordeaux PharmacoEpi, INSERM CIC-P 1401, Université de Bordeaux, Bordeaux, France.
Nicolas H ThurinBordeaux PharmacoEpi, INSERM CIC-P 1401, Université de Bordeaux, Bordeaux, France.
Sue JordanFaculty of Medicine, Health and Life Science, Swansea University, Wales, UK.
Daniel ThayerFaculty of Medicine, Health and Life Science, Swansea University, Wales, UK.
Hywel Turner EvansFaculty of Medicine, Health and Life Science, Swansea University, Wales, UK.
Alex-Ioan ColdeaFaculty of Medicine, Health and Life Science, Swansea University, Wales, UK.
Marco ManfriniDepartment of Medical Sciences, Centre for Clinical and Epidemiological Research, Ferrara University, Italy.
Marleen van GelderPharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, University of Oslo (UiO), Oslo, Norway.
Michele TariCaserta Local Health Unit, Caserta, Italy.
Romin PajouheshniaRTI Health Solutions, Department of Epidemiology, Barcelona, Spain.ORCID https://orcid.org/0000-0002-4208-3583
Ana Sofia Afonso MacielGlobal Patient Safety, Eli Lilly BV, Utrecht, the Netherlands.
Maryline Le Noan-LainéGlobal Patient Safety, Eli Lilly, Cork, Ireland.ORCID https://orcid.org/0000-0001-6616-6685
Ditte Mølgaard-NielsenGlobal Patient Safety, Novo Nordisk A/S, Soeborg, Denmark.
Marianne CunningtonAnalysis Group, Inc., London, UK.
Caitlin DoddPanalgo, Amsterdam, the Netherlands.
Leonardo GrilliDepartment of Statistics, Informatics and Applications "Giuseppe Parenti", University of Florence, Florence, Italy.
Constanza L Andaur NavarroDepartment of Data Science & Biostatistics, Julius Center, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands.
Miriam SturkenboomDepartment of Data Science & Biostatistics, Julius Center, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands.
Hedvig NordengPharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, University of Oslo (UiO), Oslo, Norway.ORCID https://orcid.org/0000-0001-6361-2918
Rosa GiniARS Toscana, Florence, Italy.ORCID https://orcid.org/0000-0002-6250-877X

Funding

European Medicines AgencyInnovative Medicines Initiative
6 · The paper itself

Abstract

purposeIn 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.

methodsData sources from six European countries were mapped to the ConcePTION Common Data Model. Any pregnancy-related record was retrieved from various available data banks, including birth register, primary care records, and hospital records, and reconciled into episodes of pregnancy (starting between 01/2015 and 12/2019), each with start date, end date, and type of end. A random forest model was used to estimate missing gestational ages for incomplete records. Parameters were tailored to data sources to address local variations in data availability, collection, and governance. Model performance was evaluated using cross-validated Root Mean Squared Error (RMSE).

resultsThe PA identified ~2.7 million pregnancies, in over 2.2 million individuals. Most ended in live births (50%-83%), 1%-15% in elective terminations, and 4%-10% in spontaneous abortions, depending on data sources. Pregnancies with unknown type of end were also retrieved (2%-34%). Gestational age was predicted for 6%-89% of records (RMSE: 17-50 days). The median gestational age at first identified pregnancy record ranged from 47 to 280 days.

conclusionsWe developed an open-source algorithm to identify and date pregnancies, including early-stage pregnancies with unknown end and/or ongoing at the time of data extraction. This algorithm may facilitate multinational studies, improving generation of timely real-world evidence about use and safety of medicinal products in pregnancy.

Indexed as

AlgorithmsDatabases, FactualElectronic Health RecordsEuropeFemaleGestational AgeHumansPrediction AlgorithmsPregnancyRandom ForestConcePTION pregnancy algorithmdiversity in data sourcesearly pregnancy detectionmulti‐database studypregnancyrandom forest

Identifiers

PMID42571911
PMCPMC13453551

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LicenceCC BY
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.