Risk of fetal or neonatal death or neonatal intensive care unit admission associated with gadolinium magnetic resonance imaging exposure during pregnancy.


Journal

American journal of obstetrics and gynecology
ISSN: 1097-6868
Titre abrégé: Am J Obstet Gynecol
Pays: United States
ID NLM: 0370476

Informations de publication

Date de publication:
04 2023
Historique:
received: 28 04 2022
revised: 30 09 2022
accepted: 05 10 2022
medline: 4 4 2023
pubmed: 15 10 2022
entrez: 14 10 2022
Statut: ppublish

Résumé

Concerns have been raised about prenatal exposure to magnetic resonance imaging with gadolinium-based contrast agents because of nonclinical findings of gadolinium retention in fetal tissue and 1 population-based study reporting an association with adverse pregnancy outcomes. This study aimed to evaluate the association between prenatal magnetic resonance imaging exposure with and without gadolinium-based contrast agents and fetal and neonatal death and neonatal intensive care unit admission. We constructed a retrospective cohort of >11 million Medicaid-covered pregnancies between 1999 and 2014 to evaluate the association between prenatal magnetic resonance imaging exposure with and without gadolinium-based contrast agents and fetal and neonatal death (primary endpoint) and neonatal intensive care unit admissions (secondary endpoint). Medicaid claims data were linked to medical records, Florida birth and fetal death records, and the National Death Index to validate the outcomes and gestational age estimates. Pregnancies with multiples, concurrent cancer, teratogenic drug exposure, magnetic resonance imaging focused on fetal or pelvic evaluation, undetermined gadolinium-based contrast agent use, or those preceded by or contemporaneous with congenital anomaly diagnoses were excluded. We adjusted for potential confounders with standardized mortality ratio weighting using propensity scores. Among 5991 qualifying pregnancies, we found 11 fetal or neonatal deaths in the gadolinium-based contrast agent magnetic resonance imaging group (1.4%) and 73 in the non-gadolinium-based contrast agent magnetic resonance imaging group (1.4%) with an adjusted relative risk of 0.73 (95% confidence interval, 0.34-1.55); the neonatal intensive care unit admission adjusted relative risk was 1.03 (0.76-1.39). Sensitivity analyses investigating the timing of magnetic resonance imaging or repeat magnetic resonance imaging exposure during pregnancy and simulating the impact of exposure misclassification corroborated these results. This study addressed the safety concerns related to prenatal exposure to gadolinium-based contrast agents used in magnetic resonance imaging and the risk thereof on fetal and neonatal death or the need for neonatal intensive care unit admission. Although the results on fatal or severe acute effects are reassuring, the impact on subacute outcomes was not evaluated.

Sections du résumé

BACKGROUND
Concerns have been raised about prenatal exposure to magnetic resonance imaging with gadolinium-based contrast agents because of nonclinical findings of gadolinium retention in fetal tissue and 1 population-based study reporting an association with adverse pregnancy outcomes.
OBJECTIVE
This study aimed to evaluate the association between prenatal magnetic resonance imaging exposure with and without gadolinium-based contrast agents and fetal and neonatal death and neonatal intensive care unit admission.
STUDY DESIGN
We constructed a retrospective cohort of >11 million Medicaid-covered pregnancies between 1999 and 2014 to evaluate the association between prenatal magnetic resonance imaging exposure with and without gadolinium-based contrast agents and fetal and neonatal death (primary endpoint) and neonatal intensive care unit admissions (secondary endpoint). Medicaid claims data were linked to medical records, Florida birth and fetal death records, and the National Death Index to validate the outcomes and gestational age estimates. Pregnancies with multiples, concurrent cancer, teratogenic drug exposure, magnetic resonance imaging focused on fetal or pelvic evaluation, undetermined gadolinium-based contrast agent use, or those preceded by or contemporaneous with congenital anomaly diagnoses were excluded. We adjusted for potential confounders with standardized mortality ratio weighting using propensity scores.
RESULTS
Among 5991 qualifying pregnancies, we found 11 fetal or neonatal deaths in the gadolinium-based contrast agent magnetic resonance imaging group (1.4%) and 73 in the non-gadolinium-based contrast agent magnetic resonance imaging group (1.4%) with an adjusted relative risk of 0.73 (95% confidence interval, 0.34-1.55); the neonatal intensive care unit admission adjusted relative risk was 1.03 (0.76-1.39). Sensitivity analyses investigating the timing of magnetic resonance imaging or repeat magnetic resonance imaging exposure during pregnancy and simulating the impact of exposure misclassification corroborated these results.
CONCLUSION
This study addressed the safety concerns related to prenatal exposure to gadolinium-based contrast agents used in magnetic resonance imaging and the risk thereof on fetal and neonatal death or the need for neonatal intensive care unit admission. Although the results on fatal or severe acute effects are reassuring, the impact on subacute outcomes was not evaluated.

Identifiants

pubmed: 36241080
pii: S0002-9378(22)00809-2
doi: 10.1016/j.ajog.2022.10.005
pii:
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

465.e1-465.e11

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.

Auteurs

Almut G Winterstein (AG)

Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL; Center for Drug Evaluation and Safety (CoDES), University of Florida, Gainesville, FL; Department of Epidemiology, College of Medicine and College of Public Health and Health Professions, University of Florida, Gainesville, FL. Electronic address: almut@ufl.edu.

Thuy N Thai (TN)

Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL; Center for Drug Evaluation and Safety (CoDES), University of Florida, Gainesville, FL; Faculty of Pharmacy, Ho Chi Minh City University of Technology (HUTECH), Ho Chi Minh City, Vietnam.

Sabina Nduaguba (S)

Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL; Center for Drug Evaluation and Safety (CoDES), University of Florida, Gainesville, FL.

Nicole E Smolinski (NE)

Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL; Center for Drug Evaluation and Safety (CoDES), University of Florida, Gainesville, FL.

Xi Wang (X)

Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL.

Leyla Sahin (L)

Division of Pediatrics and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, MD.

Ira Krefting (I)

Division of Imaging and Radiation Medicine, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.

Kate Gelperin (K)

Division of Epidemiology, Office of Surveillance and Epidemiology, CDER, FDA, Silver Spring, MD.

Steven T Bird (ST)

Division of Epidemiology, Office of Surveillance and Epidemiology, CDER, FDA, Silver Spring, MD.

Sonja A Rasmussen (SA)

Center for Drug Evaluation and Safety (CoDES), University of Florida, Gainesville, FL; Department of Epidemiology, College of Medicine and College of Public Health and Health Professions, University of Florida, Gainesville, FL; Departments of Pediatrics, College of Medicine, University of Florida, Gainesville, FL; Obstetrics and Gynecology, College of Medicine, University of Florida, Gainesville, FL.

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Classifications MeSH