Bloom Steven L, Spong Catherine Y, Thom Elizabeth, Varner Michael W, Rouse Dwight J, Weininger Sandy, Ramin Susan M, Caritis Steve N, Peaceman Alan, Sorokin Yoram, Sciscione Anthony, Carpenter Marshall, Mercer Brian, Thorp John, Malone Fergal, Harper Margaret, Iams Jay, Anderson Garland
University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.
N Engl J Med. 2006 Nov 23;355(21):2195-202. doi: 10.1056/NEJMoa061170.
Knowledge of fetal oxygen saturation, as an adjunct to electronic fetal monitoring, may be associated with a significant change in the rate of cesarean deliveries or the infant's condition at birth.
We randomly assigned 5341 nulliparous women who were at term and in early labor to either "open" or "masked" fetal pulse oximetry. In the open group, fetal oxygen saturation values were displayed to the clinician. In the masked group, the fetal oxygen sensor was inserted and the values were recorded by computer, but the data were hidden. Labor complicated by a nonreassuring fetal heart rate before randomization was documented for subsequent analysis.
There was no significant difference in the overall rates of cesarean delivery between the open and masked groups (26.3% and 27.5%, respectively; P=0.31). The rates of cesarean delivery associated with the separate indications of a nonreassuring fetal heart rate (7.1% and 7.9%, respectively; P=0.30) and dystocia (18.6% and 19.2%, respectively; P=0.59) were similar between the two groups. Similar findings were observed in the subgroup of 2168 women in whom a nonreassuring fetal heart rate was detected before randomization. The condition of the infants at birth did not differ significantly between the two groups.
Knowledge of the fetal oxygen saturation is not associated with a reduction in the rate of cesarean delivery or with improvement in the condition of the newborn. (ClinicalTrials.gov number, NCT00098709 [ClinicalTrials.gov].).
胎儿血氧饱和度作为电子胎儿监护的辅助手段，其相关知识可能与剖宫产率或出生时婴儿状况的显著变化有关。
我们将5341名足月且处于分娩早期的初产妇随机分为“开放”或“屏蔽”胎儿脉搏血氧饱和度监测组。在开放组中，向临床医生显示胎儿血氧饱和度值。在屏蔽组中，插入胎儿氧传感器并由计算机记录数值，但数据被隐藏。记录随机分组前因胎儿心率异常而使分娩复杂化的情况，以供后续分析。
开放组和屏蔽组的总体剖宫产率无显著差异（分别为26.3%和27.5%；P = 0.31）。两组中与胎儿心率异常（分别为7.1%和7.9%；P = 0.30）和难产（分别为18.6%和19.2%；P = 0.59）这两个单独指征相关的剖宫产率相似。在随机分组前检测到胎儿心率异常的2168名女性亚组中也观察到了类似结果。两组出生时婴儿的状况无显著差异。
了解胎儿血氧饱和度与剖宫产率降低或新生儿状况改善无关。（临床试验注册号，NCT00098709 [ClinicalTrials.gov]。）
