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.).
Radiology. 2019 Oct;293(1):193-200. doi: 10.1148/radiol.2019190563. Epub 2019 Aug 20.
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 ( = 3499), although pelvic and abdominal MRI constituted 22.3% ( = 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.ConclusionThis 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.© RSNA, 2019See also the editorial by Kallmes and Watson in this issue.
在怀孕期间使用钆基造影剂（GBCA）的安全性尚未确定，除非对妇女或胎儿的健康至关重要，否则不建议在怀孕期间使用 GBCA。
在大量活产妊娠中检查 GBCA 暴露的发生率。
使用 Sentinel 分布式数据库从 16 个数据合作伙伴中回顾性地确定了 2006 年至 2017 年期间导致活产的美国妊娠。主要结局是在妊娠和匹配对照女性中，按解剖部位和妊娠分期排列的 MRI 检查中 GBCA 的使用情况。
在 4692744 例活产妊娠中，我们在 5457 例妊娠中发现了 6879 例 GBCA 暴露，每 860 例妊娠中就有一例增强 MRI 检查（占所有妊娠的 0.12%）。大多数增强 MRI 检查在头部进行（=3499），尽管骨盆和腹部 MRI 占整个妊娠期间所有增强 MRI 检查的 22.3%（=1536）。大多数（70.2%）GBCA 暴露发生在妊娠早期，与妊娠中期相比，其发生率增加了 4.3 倍，与妊娠晚期相比，其发生率增加了 5.1 倍。
与妊娠后期相比，本研究发现妊娠早期 GBCA 暴露的发生率更高，这表明可能在怀孕被发现之前就意外接触到了 GBCA。
