ArticleSystematic reviews2026
Safety of anti-infective agents use during pregnancy on offspring: protocol for an umbrella review incorporating a novel three-stage data extraction strategy.
Article in Systematic reviews, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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9 authors.
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Abstract
backgroundAnti-infective agents are widely used during pregnancy to prevent, treat, and mitigate the transmission of infections, and their utilisation has significantly increased over the past decade. However, concerns persist regarding their potential embryotoxicity, compounded by inconsistencies in safety data that complicate medication decision-making. This protocol details an umbrella review that aims to provide a comprehensive and methodologically sound synthesis of evidence from systematic reviews (SRs) on the adverse effects of prenatal anti-infective exposure on offspring. The review will incorporate a standardised, three-stage data extraction strategy and an R-based algorithm to efficiently identify and manage overlapping evidence.
methodsWe will conduct a comprehensive search across six databases (PubMed, Embase, Scopus, Web of Science, Cochrane Library, and Epistemonikos) from inception to June 22, 2024. The search will cover three key concepts-pregnant women, anti-infective agents, and systematic reviews-without restrictions on controls or outcomes. We will include SRs, with or without meta-analyses, that evaluate the adverse effects of prenatal anti-infective exposure and report either neonatal outcomes (e.g. birth defects) or long-term offspring outcomes (e.g. neurodevelopmental disorders). To address overlapping evidence, a structured three-stage data extraction process, supported by an R-based algorithm, will be implemented, sequentially handling PICO definition extraction, overlapping evidence management, and quantitative data extraction. At least two independent reviewers will screen studies, extract data, and assess methodological quality and evidence strength using AMSTAR-2 and GRADE, respectively. Evidence synthesis will be conducted narratively, drawing on meta-analytic associations from direct comparative analyses and organising findings by anti-infective agents, indications, outcomes, effect estimates, certainty of evidence, and methodological quality. Anti-infectives with safety concerns will be summarised in tables and evidence maps. DISCUSSION: By adopting a standardised process that incorporates an automated algorithm for managing overlapping evidence, the planned umbrella review will provide a comprehensive synthesis of existing evidence on the adverse effects of anti-infective use during pregnancy. The findings are expected to inform clinical practice, guide policy decisions, and support infection management in pregnant patients. Furthermore, the review will identify key knowledge gaps, help prioritise future research, and ultimately contribute to improving maternal and offspring health outcomes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42024577013.
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