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一项关于胎儿脉搏血氧饱和度测定在产时胎儿心率异常模式管理中的多中心对照试验。

A multicenter controlled trial of fetal pulse oximetry in the intrapartum management of nonreassuring fetal heart rate patterns.

作者信息

Garite T J, Dildy G A, McNamara H, Nageotte M P, Boehm F H, Dellinger E H, Knuppel R A, Porreco R P, Miller H S, Sunderji S, Varner M W, Swedlow D B

机构信息

Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Orange, CA 92863-1491, USA.

出版信息

Am J Obstet Gynecol. 2000 Nov;183(5):1049-58. doi: 10.1067/mob.2000.110632.

Abstract

OBJECTIVE

Recent developments permit the use of pulse oximetry to evaluate fetal oxygenation in labor. We tested the hypothesis that the addition of fetal pulse oximetry in the evaluation of abnormal fetal heart rate patterns in labor improves the accuracy of fetal assessment and allows safe reduction of cesarean deliveries performed because of nonreassuring fetal status.

STUDY DESIGN

A randomized, controlled trial was conducted concurrently in 9 centers. The patients had term pregnancies and were in active labor when abnormal fetal heart rate patterns developed. The patients were randomized to electronic fetal heart rate monitoring alone (control group) or to the combination of electronic fetal monitoring and continuous fetal pulse oximetry (study group). The primary outcome was a reduction in cesarean deliveries for nonreassuring fetal status as a measure of improved accuracy of assessment of fetal oxygenation.

RESULTS

A total of 1010 patients were randomized, 502 to the control group and 508 to the study group. There was a reduction of >50% in the number of cesarean deliveries performed because of nonreassuring fetal status in the study group (study, 4. 5%; vs. control, 10.2%; P =.007). However, there was no net difference in overall cesarean delivery rates (study, n = 147 [29%]; vs. control, 130 [26%]; P = .49) because of an increase in cesarean deliveries performed because of dystocia in the study group. In a blinded partogram analysis 89% of the study patients and 91% of the control patients who had a cesarean delivery because of dystocia met defined criteria for actual dystocia. There was no difference between the 2 groups in adverse maternal or neonatal outcomes. In terms of the operative intervention for nonreassuring fetal status, there was an improvement in both the sensitivity and the specificity for the study group compared with the control group for the end points of metabolic acidosis and need for resuscitation.

CONCLUSION

The study confirmed its primary hypothesis of a safe reduction in cesarean deliveries performed because of nonreassuring fetal status. However, the addition of fetal pulse oximetry did not result in an overall reduction in cesarean deliveries. The increase in cesarean deliveries because of dystocia in the study group did appear to result from a well-documented arrest of labor. Fetal pulse oximetry improved the obstetrician's ability to more appropriately intervene by cesarean or operative vaginal delivery for fetuses who were actually depressed and acidotic. The unexpected increase in operative delivery for dystocia in the study group is of concern and remains to be explained.

摘要

目的

近期的技术发展使得脉搏血氧饱和度测定法可用于评估分娩时胎儿的氧合情况。我们检验了这样一个假设,即在评估分娩时异常的胎儿心率模式时增加胎儿脉搏血氧饱和度测定法,可提高胎儿评估的准确性,并能安全地减少因胎儿状况不令人放心而进行的剖宫产手术。

研究设计

在9个中心同时进行了一项随机对照试验。患者为足月妊娠,在出现异常胎儿心率模式时处于活跃期分娩。患者被随机分为仅接受电子胎儿心率监测(对照组)或接受电子胎儿监测与持续胎儿脉搏血氧饱和度测定相结合(研究组)。主要结局是因胎儿状况不令人放心而进行的剖宫产手术减少,以此作为评估胎儿氧合准确性提高的指标。

结果

共有1010例患者被随机分组,502例分到对照组,508例分到研究组。研究组因胎儿状况不令人放心而进行的剖宫产手术数量减少了50%以上(研究组为4.5%,对照组为10.2%;P = 0.007)。然而,总体剖宫产率没有净差异(研究组n = 147例[29%],对照组130例[26%];P = 0.49),因为研究组因难产而进行的剖宫产手术有所增加。在一项盲法产程图分析中,因难产进行剖宫产的研究组患者中有89%、对照组患者中有91%符合实际难产的既定标准。两组在孕产妇或新生儿不良结局方面没有差异。在针对胎儿状况不令人放心的手术干预方面,与对照组相比,研究组在代谢性酸中毒和复苏需求这两个终点上的敏感性和特异性均有所提高。

结论

该研究证实了其主要假设,即安全减少因胎儿状况不令人放心而进行的剖宫产手术。然而,增加胎儿脉搏血氧饱和度测定法并未导致剖宫产手术总体减少。研究组因难产而进行的剖宫产手术增加似乎确实是由于记录充分的产程停滞。胎儿脉搏血氧饱和度测定法提高了产科医生对实际处于抑制和酸中毒状态的胎儿进行剖宫产或阴道助产更恰当干预的能力。研究组因难产而进行的手术分娩意外增加令人担忧,仍有待解释。

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