Thacker S B, Stroup D F, Peterson H B
Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Obstet Gynecol. 1995 Oct;86(4 Pt 1):613-20.
To compare the efficacy and safety of routine electronic fetal monitoring (EFM) of labor with intermittent auscultation, using the results of published randomized controlled trials (RCTs).
We identified RCTs by searching the MED-LINE data base for the period 1966-1994, contacting experts, and reviewing published references.
Our search identified 12 published RCTs addressing the efficacy and safety of EFM; no unpublished studies were found. The studies included 58,855 pregnant women and their 59,324 infants in both high- and low-risk pregnancies from ten clinical centers in the United States, Europe, Australia, and Africa.
Data were abstracted, and their accuracy was confirmed independently. A single reviewer assessed study quality based on criteria developed by others for RCTs. Data reported from similar studies were used to calculate a combined risk estimate for each of nine outcomes. Overall, a statistically significant decrease was associated with routine EFM for a 1-minute Apgar score less than 4 (relative risk [RR] 0.82, 95% confidence interval [CI] 0.65-0.98) and neonatal seizures (RR 0.5, 95% CI 0.30-0.82). The protective effect of EFM for a 1-minute Apgar score less than 4 was apparent only in the non-United States studies, and the protective effect for neonatal seizures was evident only in studies with high-quality scores. No significant differences were observed in 1-minute Apgar scores less than 7, rate of admissions to neonatal intensive care units, and perinatal death. An increase associated with the use of EFM was observed in the rate of cesarean delivery (RR 1.33, 95% CI 1.08-1.59) and total operative delivery (RR 1.23, 95% CI 1.15-1.31). Risk of cesarean delivery was greatest in low-risk pregnancies.
The only clinically significant benefit from the use of routine EFM was in the reduction of neonatal seizures. Because of the increase in cesarean and operative vaginal deliveries, the long-term benefit of this reduction must be evaluated in the decision reached jointly by the pregnant woman and her clinician to use EFM or intermittent auscultation during labor.
利用已发表的随机对照试验(RCT)结果,比较分娩时常规电子胎儿监护(EFM)与间歇性听诊的有效性和安全性。
我们通过检索1966 - 1994年期间的MEDLINE数据库、联系专家以及查阅已发表的参考文献来确定RCT。
我们的检索确定了12项已发表的关于EFM有效性和安全性的RCT;未发现未发表的研究。这些研究纳入了来自美国、欧洲、澳大利亚和非洲十个临床中心的58855名孕妇及其59324名婴儿,涵盖高危和低危妊娠。
提取数据,并独立确认其准确性。一名评审员根据他人为RCT制定的标准评估研究质量。使用来自类似研究报告的数据计算九个结果中每个结果的综合风险估计值。总体而言,常规EFM与1分钟阿氏评分低于4分(相对风险[RR]0.82,95%置信区间[CI]0.65 - 0.98)和新生儿惊厥(RR 0.5,95% CI 0.30 - 0.82)的统计学显著降低相关。EFM对1分钟阿氏评分低于4分的保护作用仅在非美国的研究中明显,对新生儿惊厥的保护作用仅在高质量评分的研究中明显。在1分钟阿氏评分低于7分、新生儿重症监护病房收治率和围产期死亡方面未观察到显著差异。观察到使用EFM与剖宫产率(RR 1.33,95% CI 1.08 - 1.59)和总手术分娩率(RR 1.23,95% CI 1.15 - 1.31)的增加相关。剖宫产风险在低危妊娠中最大。
使用常规EFM唯一具有临床意义的益处是降低新生儿惊厥。由于剖宫产和阴道手术分娩的增加,这种降低的长期益处必须在孕妇及其临床医生共同决定在分娩时使用EFM还是间歇性听诊时进行评估。