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

被引:40
作者
Bird, Steven T. [1 ]
Gelperin, Kate [1 ]
Sahin, Leyla [2 ]
Bleich, Karen B. [3 ]
Fazio-Eynullayeva, Elnara
Woods, Corinne [1 ]
Radden, Erica [2 ,4 ,5 ]
Greene, Patty [1 ]
McCloskey, Carolyn [1 ]
Johnson, Tamara [2 ]
Shinde, Mayura [4 ,5 ]
Krefting, Ira [3 ]
机构
[1] Food & Drug Adm, Ctr Drug Evaluat & Res, Off Pharmacovigilance & Epidemiol, Div Epidemiol, 10903 New Hampshire Ave, Silver Spring, MD 20903 USA
[2] Off New Drugs, Div Pediat & Maternal Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20903 USA
[3] Off New Drugs, Div Med Imaging Prod, 10903 New Hampshire Ave, Silver Spring, MD 20903 USA
[4] Harvard Med Sch, Boston, MA USA
[5] Harvard Pilgrim Hlth Care, Boston, MA USA
关键词
UNITED-STATES; MRI; PLACENTA; DEPOSITION; DIAGNOSIS; SAFETY; BRAIN; FETAL;
D O I
10.1148/radiol.2019190563
中图分类号
R8 [特种医学]; R445 [影像诊断学];
学科分类号
1002 ; 100207 ; 1009 ;
摘要
Background: The 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. Purpose: To examine the prevalence of GBCA exposure in a large sample of pregnancies resulting in a live birth. Materials and Methods: The 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. Results: Among 4692744 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 (n = 3499), although pelvic and abdominal MRI constituted 22.3% (n = 1536) of all contrast-enhanced MRI examinations during pregnancy. The majority (70.2%) of GBCA exposures occurred during the first trimester, with a 4.3-fold greater prevalence compared with that in the second trimester and a 5.1-fold greater prevalence compared with that in the third trimester. Conclusion: This study identified higher rates of gadolinium-based contrast agent (GBCA) exposure during the first few weeks of pregnancy compared with the later weeks of pregnancy, suggesting inadvertent exposure to GBCAs might occur before pregnancy is recognized. (C) RSNA, 2019
引用
收藏
页码:193 / 200
页数:8
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