Grant A
Perinatal Trials Service, National Perinatal Epidemiology Unit, Oxford, United Kingdom.
Clin Invest Med. 1993 Apr;16(2):149-58.
There is no gold-standard measurement for 'fetal asphyxia'; methods of fetal surveillance must therefore be evaluated in the context of a management program that includes clinical intervention when a diagnosis of 'fetal compromise' is made. The use of non-randomized comparison groups is prone to major bias which can only be avoided satisfactorily by random assignment of alternative monitoring policies. To avoid being misled by random errors, randomized controlled trials must be surprisingly large. The hypothesis, generated from the results of four small trials (total of 2,000 women), that more intensive intrapartum monitoring reduces the risk of neonatal seizures, was tested and sustained in the larger Dublin trial (13,000 women). Early-onset neonatal seizures now provide the best validated epidemiological index of obstetrically-preventable intrapartum asphyxia at or after term. Paediatric follow-up at age 4 failed to identify any beneficial effect of intensive monitoring on cerebral palsy, despite the protective effect on neonatal seizures. The results of the Dublin trial are consistent with those of comparable trials, and this enhances the generalizability of the study's results.
对于“胎儿窒息”尚无金标准测量方法；因此，胎儿监测方法必须在一个管理方案的背景下进行评估，该方案包括在做出“胎儿窘迫”诊断时进行临床干预。使用非随机对照组容易出现重大偏差，只有通过随机分配替代监测策略才能令人满意地避免这种偏差。为避免被随机误差误导，随机对照试验必须规模惊人地大。从四项小型试验（共2000名女性）的结果中得出的假设，即更强化的产时监测可降低新生儿惊厥风险，在规模更大的都柏林试验（13000名女性）中得到了检验和证实。早发性新生儿惊厥现在是足月或足月后可通过产科预防的产时窒息的最佳验证流行病学指标。尽管强化监测对新生儿惊厥有保护作用，但4岁时的儿科随访未能发现其对脑瘫有任何有益影响。都柏林试验的结果与类似试验的结果一致，这增强了该研究结果的普遍性。
