ReviewDrug safety2023
Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project.
Review in Drug safety, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Estimating the Prevalence of Prescribed Medication Use in Pregnancy with a Systematic Review and Meta-analysis.Drug safety · 2026Pooled it
- Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands-A contribution of the ConcePTION project.British journal of clinical pharmacology · 2026Article
- Current Evidence on IL-17 and IL-(12)/23 Inhibitor Safety during Pregnancy in Psoriasis: A Call for Harmonized Data Collection.Acta dermato-venereologica · 2026Article
- Challenges and Insights from the Mepolizumab Pregnancy Exposure Study.Drug safety · 2026Review
- PregMedNet: Multifaceted maternal medication impacts on neonatal complications.Nature communications · 2026Article
- Safety of anti-infective agents use during pregnancy on offspring: protocol for an umbrella review incorporating a novel three-stage data extraction strategy.Systematic reviews · 2026Article
- Medicines prescribed in pregnancy: Protocol for a signal detection study using routinely collected data in England.PloS one · 2026Article
- Inconsistent medication recommendations for immune-mediated inflammatory diseases across pregnancy, lactation, and paternal preconception: a guideline-based review.Frontiers in pharmacology · 2026Review
- Suitability of Japanese Medical Databases for Studies on Infant Outcomes After Maternal Drug Exposure: An Evaluation Based on Core Data Elements.Pharmacoepidemiology and drug safety · 2025Article
- Common data elements for maternal health research: Expert consensus emerging from a modified Delphi study.Pregnancy (Hoboken, N.J.) · 2025Article
- Uncovering Pregnancy Exposures in Pharmacovigilance Case Report Databases: A Comprehensive Evaluation of the VigiBase Pregnancy Algorithm.Drug safety · 2025Article
- PregMedNet: Multifaceted Maternal Medication Impacts on Neonatal Complications.medRxiv : the preprint server for health sciences · 2025Article
- Health-Related Quality of Life and Anxiety Levels in Pregnant Women with and Without Associated Pathologies.Journal of clinical medicine · 2025Article
- Evaluation of Data Quality and Utility of the Japan Drug Information Institute in Pregnancy (JDIIP) Consultation Case Database for Pregnancy Pharmacovigilance.Drug safety · 2025Article
- Quality of Clinical Information in Pregnancy Pharmacovigilance Data Sources-A Contribution of the ConcePTION Project.Pharmacoepidemiology and drug safety · 2025Article
- Article
- Multidisciplinary DRG management for rational medication in obstetrics: a cost analysis in Zhejiang Province.BMC health services research · 2025Article
- Post-approval Activities Providing Data on the Safety of Medication Use During Pregnancy and Lactation-A TransCelerate Perspective.Therapeutic innovation & regulatory science · 2025Review
- Alcohol, Tobacco and Illicit Drug Use During Pregnancy in the Longitudinal BELpREG Cohort in Belgium Between 2022 and 2024.Journal of clinical medicine · 2025Article
- The Innovative Health Initiative public-private partnership: a catalyst for big data-driven health research and innovation.Frontiers in medicine · 2025Article
Corrections and comments
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
INTRODUCTION AND
objectiveThe risks and benefits of medication use in pregnancy are typically established through post-marketing observational studies. As there is currently no standardised or systematic approach to the post-marketing assessment of medication safety in pregnancy, data generated through pregnancy pharmacovigilance (PregPV) research can be heterogenous and difficult to interpret. The aim of this article is to describe the development of a reference framework of core data elements (CDEs) for collection in primary source PregPV studies that can be used to standardise data collection procedures and, thereby, improve data harmonisation and evidence synthesis capabilities.
methodsThis CDE reference framework was developed within the Innovative Medicines Initiative (IMI) ConcePTION project by experts in pharmacovigilance, pharmacoepidemiology, medical statistics, risk-benefit communication, clinical teratology, reproductive toxicology, genetics, obstetrics, paediatrics, and child psychology. The framework was produced through a scoping review of data collection systems used by established PregPV datasets, followed by extensive discussion and debate around the value, definition, and derivation of each data item identified from these systems.
resultsThe finalised listing of CDEs comprises 98 individual data elements, arranged into 14 tables of related fields. These data elements are openly available on the European Network of Teratology Information Services (ENTIS) website ( http://www.entis-org.eu/cde ). DISCUSSION: With this set of recommendations, we aim to standardise PregPV primary source data collection processes to improve the speed at which high-quality evidence-based statements can be provided about the safety of medication use in pregnancy.
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