East Christine E, Begg Lisa, Colditz Paul B, Lau Rosalind
School of Nursing and Midwifery/Maternity Services, Monash University/Monash Health, 246 Clayton Road, Clayton, Victoria, Australia, 3168.
Cochrane Database Syst Rev. 2014 Oct 7;2014(10):CD004075. doi: 10.1002/14651858.CD004075.pub4.
The use of conventional cardiotocographic (CTG) monitoring of fetal well-being during labour is associated with an increased caesarean section rate, compared with intermittent auscultation of the fetal heart rate, resulting in a reduction in neonatal seizures, although no differences in other neonatal outcomes. To improve the sensitivity of this test and therefore reduce the number of caesarean sections performed for nonreassuring fetal status, several additional measures of evaluating fetal well-being have been considered. These have demonstrated some effect on reducing caesarean section rates, for example, fetal scalp blood sampling for pH estimation/lactate measurement. The adaptation of pulse oximetry for use in the unborn fetus could potentially contribute to improved evaluation during labour and therefore lead to a reduction in caesarean sections for nonreassuring fetal status, without any change in neonatal outcomes.
To compare the effectiveness and safety of fetal intrapartum pulse oximetry with other surveillance techniques.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2014), contacted experts in the field and searched reference lists of retrieved studies. In previous versions of this review, we performed additional searches of MEDLINE, Embase and Current Contents. These searches were discontinued for this review update, as they consistently failed to identify any trials that were not shown in the Cochrane Pregnancy and Childbirth Group's Trials Register.
All published and unpublished randomised controlled trials that compared maternal and fetal outcomes when fetal pulse oximetry was used in labour, (i) with or without concurrent use of conventional fetal surveillance, that is, cardiotocography (CTG), compared with using CTG alone or (ii) with or without concurrent use of both CTG and other method(s) of fetal surveillance, such as fetal electrocardiography (ECG) plus CTG.
At least two independent review authors performed data extraction. We sought additional information from the investigators of three of the reported trials.
We included seven published trials: six comparing fetal pulse oximetry and CTG with CTG alone (or when fetal pulse oximetry values were blinded) and one comparing fetal pulse oximetry plus CTG with fetal ECG plus CTG. The published trials, with some unpublished data, were at high risk of bias in terms of the impractical nature of blinding participants and clinicians, as well as high risk or unclear risk of bias for outcome assessor for all but one report. Selection bias, attrition bias, reporting bias and other sources of bias were of low or unclear risk. The trials reported on a total of 8013 pregnancies. Differing entry criteria necessitated separate analyses, rather than meta-analysis of all trials.Systematic review of four trials from 34 weeks not requiring fetal blood sampling (FBS) prior to study entry showed no evidence of differences in the overall caesarean section rate between those monitored with fetal oximetry and those not monitored with fetal pulse oximetry or for whom the fetal pulse oximetry results were masked (average risk ratio (RR) 0.99 using random-effects, 95% confidence intervals (CI) 0.86 to 1.13, n = 4008, I² = 45%). There was evidence of a higher risk of caesarean section in the group with fetal oximetry plus CTG than in the group with fetal ECG plus CTG (one study, n = 180, RR 1.56, 95% CI 1.06 to 2.29). Neonatal seizures and neonatal encephalopathy were rare in both groups. No studies reported details of long-term disability.There was evidence of a decrease in caesarean section for nonreassuring fetal status in the fetal pulse oximetry plus CTG group compared to the CTG group, gestation from 34 weeks (average RR (random-effects) 0.65, 95% CI 0.46 to 0.90, n = 4008, I² = 63%). There was no evidence of differences between groups in caesarean section for dystocia, although the overall incidence rates varied between the trials.
AUTHORS' CONCLUSIONS: The addition of fetal pulse oximetry does not reduce overall caesarean section rates. One study found a higher caesarean section rate in the group monitored with fetal pulse oximetry plus CTG, compared with fetal ECG plus CTG. The data provide limited support for the use of fetal pulse oximetry when used in the presence of a nonreassuring CTG, to reduce caesarean section for nonreassuring fetal status. A better method than pulse oximetry is required to enhance the overall evaluation of fetal well-being in labour.
与间歇性听诊胎儿心率相比,在分娩期间使用传统的胎心监护(CTG)监测胎儿健康状况会导致剖宫产率增加,尽管新生儿其他结局无差异,但可降低新生儿惊厥的发生率。为提高该检查的敏感性,从而减少因胎儿状况不令人放心而进行的剖宫产数量,人们考虑了几种评估胎儿健康状况的额外措施。这些措施已证明对降低剖宫产率有一定作用,例如,胎儿头皮血采样用于pH值估计/乳酸测量。将脉搏血氧饱和度测定法应用于未出生胎儿可能有助于改善分娩期间的评估,从而减少因胎儿状况不令人放心而进行的剖宫产,且不会改变新生儿结局。
比较胎儿产时脉搏血氧饱和度测定法与其他监测技术的有效性和安全性。
我们检索了Cochrane妊娠与分娩组试验注册库(2014年5月31日),联系了该领域的专家,并检索了所获研究的参考文献列表。在本综述的前几版中,我们还对MEDLINE、Embase和《现刊目次》进行了额外检索。由于这些检索一直未能识别出Cochrane妊娠与分娩组试验注册库中未显示的任何试验,因此在本次综述更新时停止了这些检索。
所有已发表和未发表的随机对照试验,这些试验比较了在分娩时使用胎儿脉搏血氧饱和度测定法(i)无论是否同时使用传统胎儿监测方法,即胎心监护(CTG),与单独使用CTG相比,或(ii)无论是否同时使用CTG和其他胎儿监测方法,如胎儿心电图(ECG)加CTG时的母婴结局。
至少两名独立的综述作者进行了数据提取。我们向三项已报告试验的研究者寻求了更多信息。
我们纳入了七项已发表的试验:六项试验比较了胎儿脉搏血氧饱和度测定法和CTG与单独使用CTG(或胎儿脉搏血氧饱和度测定值被设盲时),一项试验比较了胎儿脉搏血氧饱和度测定法加CTG与胎儿心电图加CTG。已发表的试验,包括一些未发表的数据,在使参与者和临床医生设盲的不切实际性方面存在高偏倚风险,并且除一份报告外,所有报告的结局评估者的偏倚风险均为高风险或不明确。选择偏倚、失访偏倚、报告偏倚和其他偏倚来源的风险较低或不明确。这些试验共报告了8013例妊娠。不同的纳入标准需要单独分析,而不是对所有试验进行荟萃分析。对34周起入组前无需进行胎儿血样采集(FBS)的四项试验进行系统综述表明,在使用胎儿脉搏血氧饱和度测定法监测的孕妇与未使用胎儿脉搏血氧饱和度测定法监测或胎儿脉搏血氧饱和度测定结果被掩盖的孕妇之间,总体剖宫产率无差异证据(随机效应模型下平均风险比(RR)为0.99,95%置信区间(CI)为0.86至1.13,n = 4008,I² = 45%)。有证据表明,胎儿脉搏血氧饱和度测定法加CTG组的剖宫产风险高于胎儿心电图加CTG组(一项研究,n = 180,RR 1.56,95%CI 1.06至2.29)。两组新生儿惊厥和新生儿脑病均罕见。没有研究报告长期残疾的细节。有证据表明,与CTG组相比,胎儿脉搏血氧饱和度测定法加CTG组因胎儿状况不令人放心而进行的剖宫产有所减少,孕周从34周起(平均RR(随机效应)0.65,95%CI 0.46至0.90,n = 4008,I² = 63%)。尽管各试验之间总体发生率有所不同,但在因难产进行剖宫产方面,两组之间没有差异证据。
增加胎儿脉搏血氧饱和度测定法并不能降低总体剖宫产率。一项研究发现,与胎儿心电图加CTG组相比,胎儿脉搏血氧饱和度测定法加CTG组的剖宫产率更高。这些数据为在CTG不令人放心的情况下使用胎儿脉搏血氧饱和度测定法以减少因胎儿状况不令人放心而进行的剖宫产提供了有限的支持。需要一种比脉搏血氧饱和度测定法更好的方法来加强对分娩时胎儿健康状况的总体评估。