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Original Investigation |

Association Between MRI Exposure During Pregnancy and Fetal and Childhood Outcomes

Joel G. Ray, MD, MSc, FRCPC1,2,3,5; Marian J. Vermeulen, BScN, MHSc2,3; Aditya Bharatha, MD, FRCPC3,4; Walter J. Montanera, MD, FRCPC3,4; Alison L. Park, MSc2,5
[+] Author Affiliations
1Departments of Medicine, and Obstetrics and Gynecology, St Michael’s Hospital, Toronto, Ontario, Canada
2Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada
3University of Toronto, Toronto, Ontario, Canada
4Department of Medical Imaging, St Michael’s Hospital, Toronto, Ontario, Canada
5Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Ontario, Canada
JAMA. 2016;316(9):952-961. doi:10.1001/jama.2016.12126.
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Importance  Fetal safety of magnetic resonance imaging (MRI) during the first trimester of pregnancy or with gadolinium enhancement at any time of pregnancy is unknown.

Objective  To evaluate the long-term safety after exposure to MRI in the first trimester of pregnancy or to gadolinium at any time during pregnancy.

Design, Setting, and Participants  Universal health care databases in the province of Ontario, Canada, were used to identify all births of more than 20 weeks, from 2003-2015.

Exposures  Magnetic resonance imaging exposure in the first trimester of pregnancy, or gadolinium MRI exposure at any time in pregnancy.

Main Outcomes and Measures  For first-trimester MRI exposure, the risk of stillbirth or neonatal death within 28 days of birth and any congenital anomaly, neoplasm, and hearing or vision loss was evaluated from birth to age 4 years. For gadolinium-enhanced MRI in pregnancy, connective tissue or skin disease resembling nephrogenic systemic fibrosis (NSF-like) and a broader set of rheumatological, inflammatory, or infiltrative skin conditions from birth were identified.

Results  Of 1 424 105 deliveries (48% girls; mean gestational age, 39 weeks), the overall rate of MRI was 3.97 per 1000 pregnancies. Comparing first-trimester MRI (n = 1737) to no MRI (n = 1 418 451), there were 19 stillbirths or deaths vs 9844 in the unexposed cohort (adjusted relative risk [RR], 1.68; 95% CI, 0.97 to 2.90) for an adjusted risk difference of 4.7 per 1000 person-years (95% CI, −1.6 to 11.0). The risk was also not significantly higher for congenital anomalies, neoplasm, or vision or hearing loss. Comparing gadolinium MRI (n = 397) with no MRI (n = 1 418 451), the hazard ratio for NSF-like outcomes was not statistically significant. The broader outcome of any rheumatological, inflammatory, or infiltrative skin condition occurred in 123 vs 384 180 births (adjusted HR, 1.36; 95% CI, 1.09 to 1.69) for an adjusted risk difference of 45.3 per 1000 person-years (95% CI, 11.3 to 86.8). Stillbirths and neonatal deaths occurred among 7 MRI-exposed vs 9844 unexposed pregnancies (adjusted RR, 3.70; 95% CI, 1.55 to 8.85) for an adjusted risk difference of 47.5 per 1000 pregnancies (95% CI, 9.7 to 138.2).

Conclusions and Relevance  Exposure to MRI during the first trimester of pregnancy compared with nonexposure was not associated with increased risk of harm to the fetus or in early childhood. Gadolinium MRI at any time during pregnancy was associated with an increased risk of a broad set of rheumatological, inflammatory, or infiltrative skin conditions and for stillbirth or neonatal death. The study may not have been able to detect rare adverse outcomes.

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Figure 1.
Flowchart of Formation of Cohorts Exposed to Magnetic Resonance Imaging Alone in the First Trimester, With Gadolinium Enhancement in Any Trimester, or Unexposed
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Figure 2.
Proportion of All First-Trimester Magnetic Resonance Imaging by Completed Gestational Week at Exposure

There were 1720 women who underwent magnetic resonance imaging during their first trimester of pregnancy. Error bars indicate 95% confidence intervals.

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Figure 3.
Incidence Rate of a Congenital Anomaly in Relation to Magnetic Resonance Imaging Exposure Within Each Completed Gestational Week

Data are presented for magnetic resonance imaging (MRI) completed within the first trimester of pregnancy. A total of 4884 completed person-years were included in this analysis. Error bars indicate 95% confidence intervals.

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