First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies.

Abdomen / diagnostic imaging Adult Brain / diagnostic imaging Contrast Media / administration & dosage Female Gadolinium / administration & dosage Humans Image Enhancement / methods Live Birth Magnetic Resonance Imaging / methods Pelvis / diagnostic imaging Pregnancy Pregnancy Trimester, First Retrospective Studies United States Young Adult

Journal

Radiology
ISSN: 1527-1315
Titre abrégé: Radiology
Pays: United States
ID NLM: 0401260

Informations de publication

Date de publication:
10 2019
Historique:
pubmed: 21 8 2019
medline: 11 3 2020
entrez: 21 8 2019
Statut: ppublish

Résumé

BackgroundThe safety of gadolinium-based contrast agent (GBCA) exposure during pregnancy has not been established, and the use of GBCAs during pregnancy is not recommended unless it is essential to the health of the woman or fetus.PurposeTo examine the prevalence of GBCA exposure in a large sample of pregnancies resulting in a live birth.Materials and MethodsThe Sentinel Distributed Database was used to retrospectively identify U.S. pregnancies that resulted in live births between 2006 and 2017 from 16 data partners. The main outcome was the prevalence of MRI procedures with and without GBCAs, sorted by anatomic location and trimester, among pregnant and matched comparator women.ResultsAmong 4 692 744 pregnancies resulting in a live birth, we identified 6879 exposures to GBCAs in 5457 pregnancies, representing one contrast-enhanced MRI examination per 860 pregnancies (0.12% of all pregnancies). Most contrast-enhanced MRI examinations were performed in the head (

Identifiants

DOI: 10.1148/radiol.2019190563 PMID: 31429682
pubmed: 31429682
doi: 10.1148/radiol.2019190563
doi:

Substances chimiques

Contrast Media 0
Gadolinium AU0V1LM3JT

Types de publication

Journal Article Research Support, U.S. Gov't, P.H.S.

Langues

eng

Sous-ensembles de citation

IM

Pagination

193-200

Commentaires et corrections

Type : CommentIn

Auteurs

Steven T Bird (ST)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).
ORCID: 0000-0001-7976-3462

Kate Gelperin (K)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).

Leyla Sahin (L)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).

Karen B Bleich (KB)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).

Elnara Fazio-Eynullayeva (E)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).
ORCID: 0000-0002-0594-0275

Corinne Woods (C)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).

Erica Radden (E)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).

Patty Greene (P)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).
ORCID: 0000-0002-2346-2027

Carolyn McCloskey (C)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).
ORCID: 0000-0003-2827-9384

Tamara Johnson (T)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).

Mayura Shinde (M)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).

Ira Krefting (I)

From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Products (K.B.B, I.K), 10903 New Hampshire Ave, Silver Spring, MD 20903; and Harvard Medical School and Harvard Pilgrim Health Care, Boston, Mass (E.F., M.S.).
ORCID: 0000-0003-1186-1319

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Classifications MeSH

questionsmedicales.fr › Régions du corps › Tronc › Abdomen › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Système nerveux › Système nerveux central › Encéphale › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Actions chimiques et utilisations › Utilisations spécialisées de produits chimiques › Produits de contraste › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Produits chimiques inorganiques › Métaux › Terres rares › Lanthanides › Gadolinium › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Sciences de l'information › Méthodologies informatiques › Traitement d'image par ordinateur › Amélioration d'image › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Reproduction › Grossesse › Issue de la grossesse › Naissance vivante › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Imagerie diagnostique › Tomographie › Imagerie par résonance magnétique › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Régions du corps › Tronc › Pelvis › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Reproduction › Grossesse › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Trimestres de grossesse › Premier trimestre de grossesse › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études rétrospectives › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › First-Trimester Exposure to Gadolinium-based...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Jeune adulte › First-Trimester Exposure to Gadolinium-based...