ReviewPharmacoepidemiology and drug safety2019
Use of real-world evidence from healthcare utilization data to evaluate drug safety during pregnancy.
Review in Pharmacoepidemiology and drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 2 of them syntheses that pooled it.
What it found
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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.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
66 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Algorithms to Identify Major Congenital Malformations in Routinely Collected Healthcare Data: A Systematic Review.Drug safety · 2026Pooled it
- Prevalence of systemic antibacterial use during pregnancy worldwide: A systematic review.PloS one · 2024Pooled it
- Validation of Claims-Based Algorithms for Identifying Congenital Urinary Tract, Genital, Gastrointestinal, and Musculoskeletal Malformations.Pharmacoepidemiology and drug safety · 2026Article
- A new tool for pregnancy research: a unified definition for major congenital malformation across ICD eras.American journal of epidemiology · 2026Article
- Medication use during pregnancy in Japan from 2005 to 2019: Trends and safety considerations.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Article
- Exposure Definitions in Perinatal Pharmacoepidemiology: One Size Does Not Fit All.Paediatric and perinatal epidemiology · 2026Article
- Use of prescription medications potentially harmful during pregnancy among women of reproductive age by pregnancy status and contraceptive use in the United States, 2009-2020.Reproductive health · 2026Article
- PregMedNet: Multifaceted maternal medication impacts on neonatal complications.Nature communications · 2026Article
- Use of multiple sclerosis drugs among pregnant individuals with live-birth deliveries in the FDA's Sentinel Distributed Database.BMC pregnancy and childbirth · 2026Article
- Prenatal Prescription Opioid Analgesic Exposure and Academic Performance in Third Grade Children: A Population-Based Cohort Study.BJOG : an international journal of obstetrics and gynaecology · 2026Article
- Pregnancy identification method as a source of bias in studies of prenatal exposures using real-world data.American journal of epidemiology · 2026Article
- Machine Learning Estimation of Gestational Age at Delivery Using Linked Mother-Infant Electronic Health Records Across Two Health Systems.medRxiv : the preprint server for health sciences · 2026Article
- Benzodiazepine exposure during early pregnancy and risk of miscarriage: dose-response, half-life classification, and individual agents.Archives of women's mental health · 2026Article
- Risk of Major Congenital Malformations Associated With the First-Trimester Exposure to Antipsychotics: A Large Claims Database Study.Pharmacology research & perspectives · 2026Article
- Healthy Live Births as Censoring Versus Competing Events in Studies of Prenatal Medication Use.Paediatric and perinatal epidemiology · 2026Article
- From card to cradle: examining medical cannabis purchasing among pregnant women in Arkansas.American journal of obstetrics & gynecology MFM · 2026Article
- Article
- Validity of diagnostic codes used to ascertain maternal injuries during pregnancy.American journal of epidemiology · 2025Article
- Linking deliveries to newborns using nationwide Medicaid data.BMC medical research methodology · 2025Article
- PregMedNet: Multifaceted Maternal Medication Impacts on Neonatal Complications.medRxiv : the preprint server for health sciences · 2025Article
6 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
purposeBecause preapproval clinical trials typically exclude pregnant women, the evidence on drug safety during pregnancy required to inform drug labeling must come from postapproval controlled observational studies. Common designs have included pregnancy registries and case-control studies. Recently, pregnancy cohorts nested within healthcare utilization databases are increasingly being used. Despite clear advantages, these databases share some important limitations that may threaten the validity of studies emerging from them.
methodsThis paper describes the distinctive methodological aspects of conducting drug safety studies in healthcare utilization databases with special emphasis on design and analytic approaches to minimize biases.
resultsWe describe considerations for study design, cohort definition, and follow-up. We then address issues related to exposure ascertainment based on prescription fills, including the importance of the etiologically relevant window and of properly accounting for preterm births. This is followed by a discussion of advantages and challenges when ascertaining maternal and infant outcomes based on secondary data. We then explore useful approaches to address confounding within the context of pregnancy research and of the potential for selection bias when restricting the cohort to live births. Finally, we consider issues related to external validity and statistical significance. The examples are mainly drawn from a pregnancy cohort nested in the Medicaid Analytic Extract.
conclusionsThe approaches presented provide guidance regarding the important methodological considerations that need to be attended to in order to generate valid, minimally biased risk when using large healthcare utilization databases for drug safety surveillance in pregnancy.
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