Thornton J G, Hornbuckle J, Vail A, Spiegelhalter D J, Levene M
Lancet. 2004;364(9433):513-20. doi: 10.1016/S0140-6736(04)16809-8.
Although delivery is widely used for preterm babies failing to thrive in utero, the effect of altering delivery timing has never been assessed in a randomised controlled trial. We aimed to compare the effect of delivering early with delaying birth for as long as possible.
548 pregnant women were recruited by 69 hospitals in 13 European countries. Participants had fetal compromise between 24 and 36 weeks, an umbilical-artery doppler waveform recorded, and clinical uncertainty about whether immediate delivery was indicated. Before birth, 588 babies were randomly assigned to immediate delivery (n=296) or delayed delivery until the obstetrician was no longer uncertain (n=292). The main outcome was death or disability at or beyond 2 years of age. Disability was defined as a Griffiths developmental quotient of 70 or less or the presence of motor or perceptual severe disability. Analysis was by intention-to-treat. This trial has been assigned the International Standard Randomised Controlled Trial Number ISRCTN41358726.
Primary outcomes were available on 290 (98%) immediate and 283 (97%) deferred deliveries. Overall rate of death or severe disability at 2 years was 55 (19%) of 290 immediate births, and 44 (16%) of 283 delayed births. With adjustment for gestational age and umbilical-artery doppler category, the odds ratio (95% CrI) was 1.1 (0.7-1.8). Most of the observed difference was in disability in babies younger than 31 weeks of gestation at randomisation: 14 (13%) immediate versus five (5%) delayed deliveries. No important differences in the median Griffiths developmental quotient in survivors was seen.
The lack of difference in mortality suggests that obstetricians are delivering sick preterm babies at about the correct moment to minimise mortality. However, they could be delivering too early to minimise brain damage. These results do not lend support to the idea that obstetricians can deliver before terminal hypoxaemia to improve brain development.
尽管分娩广泛应用于子宫内发育不良的早产儿，但改变分娩时机的效果从未在随机对照试验中得到评估。我们旨在比较尽早分娩与尽可能延迟分娩的效果。
13个欧洲国家的69家医院招募了548名孕妇。参与者在孕24至36周之间出现胎儿窘迫，记录了脐动脉多普勒波形，且对于是否立即分娩存在临床不确定性。出生前，588名婴儿被随机分配至立即分娩组（n = 296）或延迟分娩组，直至产科医生不再存在不确定性（n = 292）。主要结局是2岁及以后的死亡或残疾。残疾定义为格里菲斯发育商为70或更低，或存在运动或感知方面的严重残疾。分析采用意向性分析。该试验已被分配国际标准随机对照试验编号ISRCTN41358726。
290例（98%）立即分娩和283例（97%）延迟分娩获得了主要结局数据。2岁时死亡或严重残疾的总体发生率在290例立即分娩的婴儿中为55例（19%），在283例延迟分娩的婴儿中为44例（16%）。校正胎龄和脐动脉多普勒类别后，比值比（95%可信区间）为1.1（0.7 - 1.8）。观察到的差异主要存在于随机分组时孕周小于31周的婴儿的残疾情况：立即分娩组14例（13%），延迟分娩组5例（5%）。幸存者的格里菲斯发育商中位数未见重要差异。
死亡率无差异表明，产科医生在大致正确的时机分娩患病早产儿以尽量降低死亡率。然而，他们可能分娩得过早，无法将脑损伤降至最低。这些结果不支持产科医生可在终末期低氧血症之前分娩以改善脑发育的观点。
