Moore R M, Jeng L L, Kaczmarek R G, Placek P J
Epidemiology Branch, Food and Drug Administration, Rockville, MD.
Public Health Rep. 1990 Sep-Oct;105(5):471-5.
Medical devices and diagnostic imaging procedures such as ultrasound, X-rays, and electronic fetal monitoring devices are used in the medical care of many pregnant women today. The responsibility for the safety and effectiveness of these diagnostic technologies is shared by a number of Public Health Service agencies, one of which is the Center for Devices and Radiological Health (CDRH), a unit within the Food and Drug Administration. The CDRH collaborated with the National Center for Health Statistics (NCHS) in conducting a study of recent trends in the uses of diagnostic ultrasound, medical X-rays, and electronic fetal monitoring devices in the medical care of pregnant women. This study used data from the 1980 National Natality and Fetal Mortality Surveys and the 1987 pretest to the National Maternal and Infant Health Survey. Hospitals and prenatal care providers of the pregnant women contributed information regarding the use of these medical devices. Between 1980 and 1987, ultrasound use more than doubled, increasing from 33.5 percent of pregnancies in 1980 to 78.8 percent in 1987 (P less than 0.001). More ultrasound examinations were performed earlier in gestation in 1987 than in 1980, with 10.1 percent being performed during the first trimester in 1987, compared with 6.9 percent in 1980 (P less than 0.001). Use of external electronic fetal monitoring devices during delivery also increased significantly between 1980 and 1987, from 33.5 percent to 74.6 percent (P less than 0.001). Use of medical X-rays among women with live births remained relatively unchanged, 15.0 percent in 1980 and 15.3 percent in 1987 (P = .282). The implications of these trends are discussed.
如今,医疗设备以及超声、X光和电子胎儿监护设备等诊断成像程序被用于众多孕妇的医疗护理中。这些诊断技术的安全性和有效性由多个公共卫生服务机构共同负责,其中之一是食品药品监督管理局下属的设备与放射卫生中心(CDRH)。CDRH与国家卫生统计中心(NCHS)合作,对孕妇医疗护理中诊断性超声、医用X光和电子胎儿监护设备的使用近期趋势进行了一项研究。本研究使用了1980年全国出生与胎儿死亡调查以及1987年全国母婴健康调查预试验的数据。孕妇的医院和产前护理提供者提供了有关这些医疗设备使用情况的信息。1980年至1987年间,超声的使用增加了一倍多,从1980年怀孕孕妇的33.5%增至1987年的78.8%(P<0.001)。1987年与1980年相比,妊娠早期进行的超声检查更多,1987年有10.1%在孕早期进行,而1980年为6.9%(P<0.001)。1980年至1987年间,分娩期间外部电子胎儿监护设备的使用也显著增加,从33.5%增至74.6%(P<0.001)。活产妇女中医用X光的使用相对保持不变,1980年为15.0%,1987年为15.3%(P = 0.282)。文中讨论了这些趋势的影响。