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• W4385605192 abstract "We read with great interest and appreciation the recent study by Winterstein et al,1Winterstein A.G. Thai T.N. Nduaguba S. et al.Risk of fetal or neonatal death or neonatal intensive care unit admission associated with gadolinium magnetic resonance imaging exposure during pregnancy.Am J Obstet Gynecol. 2023; 228: 465.e1-465.e11Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar which reported that there is no elevated risk for fetal or neonatal death or neonatal intensive care unit admission related to gadolinium-based contrast agents (GBCA) used in magnetic resonance imaging (MRI) during pregnancy. We congratulate the authors on the important work that evaluated the safety concerns related to prenatal exposure to MRIs with GBCA. However, we would like to raise 2 concerns from the perspective of clinical practice. We first have concerns about the extent to which the study endpoints used in the study by Winterstein et al1Winterstein A.G. Thai T.N. Nduaguba S. et al.Risk of fetal or neonatal death or neonatal intensive care unit admission associated with gadolinium magnetic resonance imaging exposure during pregnancy.Am J Obstet Gynecol. 2023; 228: 465.e1-465.e11Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar addressed the safety concerns related to GBCA in the context of clinical practice. In the study, the authors identified the primary and secondary endpoints, which were fetal or neonatal death and infant admission to a neonatal intensive care unit, respectively. However, it is important to note that it was not ascertained if these outcomes are directly related to GBCA used in MRI in the study.1Winterstein A.G. Thai T.N. Nduaguba S. et al.Risk of fetal or neonatal death or neonatal intensive care unit admission associated with gadolinium magnetic resonance imaging exposure during pregnancy.Am J Obstet Gynecol. 2023; 228: 465.e1-465.e11Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar Moreover, there are many different causes that can lead to fetal or neonatal death with common causes, such as neonatal defects, infections, especially blood infections, and complications of preterm birth.2What causes infant mortality? National Institute of Child Health and Human Development. 2011.https://www.nichd.nih.gov/health/topics/infant-mortality/topicinfo/causesDate accessed: April 18, 2023Google Scholar Similarly, the selection of neonatal intensive care unit admission as a proxy for severe acute neonatal effects of GBCA retention remains questionable, being highly heterogeneous with diverse causes. In any case, however, GBCA-related deaths or intensive care unit admission as adverse an outcome is extremely rare, either in pregnant women or among the general population of individuals. In addition to the risk-benefit trade-off based on the previously mentioned safety concerns of the rare but serious events, other contrast-related adverse effects (eg, allergic reactions) and the possible effects associated with performing MRI (eg, noise and heat)3Fraum T.J. Ludwig D.R. Bashir M.R. Fowler K.J. Gadolinium-based contrast agents: a comprehensive risk assessment.J Magn Reson Imaging. 2017; 46: 338-353Crossref PubMed Scopus (232) Google Scholar are likewise taken into account during the decision-making in clinical practice settings. We are also concerned about the generalizability of the study findings because of the restrictive inclusion criteria. As acknowledged by the authors, using restrictive inclusion criteria aided in establishing balanced comparison groups while excluding pregnancies with MRIs linked to fetal evaluation or emerging pregnancy concerns. This was likely to remove some pregnancies at higher risk for fetal or neonatal death, however, this is the population with a greater likelihood of exposure to MRIs with GBCA and deserves to be prioritized. We believe it may be informative to see the results with the analyses including such population profiles. Trade-offs in safety study design decisions on teratogenic gadolinium effectsAmerican Journal of Obstetrics & GynecologyPreviewWe appreciate the letter by Drs Jiang and Chen who raised 2 interrelated concerns about our safety study on teratogenic effects of gadolinium-related contrast agents.1 First, causal inferences about drug effects are commonly made based on quantitative comparisons with control groups because direct assessments, as requested by the authors, are infeasible, especially if biologic pathways are unclear. We agree with the authors that stillbirths and sudden infant deaths, the outcomes that were implicated with prenatal gadolinium exposure in a previous study,2 share other risk factors, which is the reason why we confined our assessments to magnetic resonance imaging (MRI) and gadolinium exposures that were unrelated to pregnancy. Full-Text PDF" @default.
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• W4385605192 title "Safety concerns related to prenatal exposure to gadolinium magnetic resonance imaging" @default.
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• W4385605192 doi "https://doi.org/10.1016/j.ajog.2023.08.002" @default.
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