Moore R M, Jeng L L, Kaczmarek R G, Placek P J
Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20852.
J Perinatol. 1990 Dec;10(4):361-5.
Obstetrical technologies such as electronic fetal monitoring (EFM) and selected diagnostic imaging procedures can be integral components of perinatal care. The Center for Devices and Radiological Health, a unit within the Food and Drug Administration, collaborated with the National Center for Health Statistics in the design and conduct of a National Maternal and Infant Health Survey to collect information from prenatal care providers, hospitals, and mothers on the use of EFM, diagnostic ultrasound, and x-ray examinations during pregnancy, labor, and delivery. A pretest, conducted some months before the survey began, showed that 78.8% of the pregnancies surveyed received a diagnostic ultrasound examination during pregnancy. Approximately 58.3% of the ultrasound-exposed mothers had two or more such examinations. Approximately 10.1% of the ultrasound examinations were performed in the first trimester of pregnancy, 57.0% in the second trimester, and 32.9% in the third trimester. The most common indication for an ultrasound examination was to establish dates or gestational age. Approximately 15.3% of the pregnancies surveyed received an x-ray examination. Approximately 74.6% of the pregnancies were monitored with EFM during labor. External EFM was used alone during 54.9% of the labors and along with internal EFM during 19.7% of the labors. The implications of these pretest findings are discussed, along with a review of the medical literature on the safety and effectiveness of these medical device technologies.
诸如电子胎儿监护(EFM)和某些诊断成像程序等产科技术可以成为围产期护理的重要组成部分。美国食品药品监督管理局下属的设备与放射健康中心与国家卫生统计中心合作,设计并开展了一项全国母婴健康调查,以收集来自产前护理提供者、医院和母亲的关于孕期、分娩期和产程中EFM、诊断性超声和X线检查使用情况的信息。在调查开始前几个月进行的预测试显示,接受调查的孕妇中有78.8%在孕期接受了诊断性超声检查。约58.3%接受超声检查的母亲进行了两次或更多次此类检查。约10.1%的超声检查在孕早期进行,57.0%在孕中期进行,32.9%在孕晚期进行。超声检查最常见的指征是确定孕周或胎龄。接受调查的孕妇中有约15.3%接受了X线检查。约74.6%的孕妇在分娩期接受了EFM监测。54.9%的分娩仅使用了外部EFM,19.7%的分娩同时使用了外部和内部EFM。本文讨论了这些预测试结果的意义,并对有关这些医疗设备技术安全性和有效性的医学文献进行了综述。