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胎儿头皮血乳酸测量作为胎心监护的辅助手段,以减少分娩时的剖宫产:Flamingo 随机对照试验。

The addition of fetal scalp blood lactate measurement as an adjunct to cardiotocography to reduce caesarean sections during labour: The Flamingo randomised controlled trial.

机构信息

Judith Lumley Centre & School of Nursing and Midwifery, La Trobe University, Melbourne, Victoria, Australia.

Department of Maternal-Fetal Medicine, Pregnancy Research Centre, Royal Women's Hospital, Melbourne, Victoria, Australia.

出版信息

Aust N Z J Obstet Gynaecol. 2021 Oct;61(5):684-692. doi: 10.1111/ajo.13327. Epub 2021 Mar 23.

Abstract

BACKGROUND

Fetal scalp blood sampling for lactate measurement (FBSLM) is sometimes used to assist in identification of the need for expedited birth in the presence of an abnormal cardiotocograph (CTG). However, there is no randomised controlled trial evidence to support this.

AIM

To determine whether adding FBSLM reduces the risk of birth by emergency caesarean section in labours complicated by an abnormal CTG, compared with CTG without FBS.

MATERIAL AND METHODS

Labouring women at a tertiary maternity hospital in Melbourne, Australia with a singleton, cephalic presentation, at ≥37 weeks gestation with an abnormal CTG pattern were randomised to the intervention (n = 61), with intermittent FBSLM in addition to CTG monitoring, or control (CTG without FBS, n = 62). The primary outcome was rate of birth by caesarean section. Secondary outcomes included overall operative birth and fetal and neonatal safety endpoints.

TRIAL REGISTRATION

ACTRN12611000172909.

RESULTS

The smaller than anticipated sample was unable to demonstrate an effect from adding FBSLM to CTG monitoring on birth by caesarean section vs monitoring by CTG without FBS (25/61 and 28/62 respectively, P = 0.64, risk ratio 0.91, 95% confidence intervals 0.60-1.36). One newborn infant in the CTG group met the criteria for the composite neonatal outcome of death or serious outcome, neonatal encephalopathy, five-minute Apgar score < 4, neonatal resuscitation, admission to neonatal intensive care unit for 96 h or more.

CONCLUSION

We were unable to provide robust evidence of the effectiveness of FBSLM to improve the specificity of the CTG in the assessment of fetal wellbeing.

摘要

背景

胎儿头皮血乳酸测量(FBSLM)有时用于协助识别异常胎心监护图(CTG)存在时加速分娩的必要性。然而,目前没有随机对照试验证据支持这一点。

目的

与无 FBSLM 的 CTG 相比,确定在 CTG 异常的产程中,添加 FBSLM 是否会降低紧急剖宫产分娩的风险。

材料和方法

在澳大利亚墨尔本的一家三级妇产医院,对胎龄≥37 周、头位、CTG 异常模式的单胎产妇进行随机分组,干预组(n=61)在 CTG 监测的基础上间断进行 FBSLM,对照组(CTG 无 FBSLM,n=62)。主要结局是剖宫产分娩率。次要结局包括总手术分娩和胎儿及新生儿安全性结局。

试验注册

ACTRN12611000172909。

结果

预期样本量较小,无法证明在 CTG 监测的基础上添加 FBSLM 对 CTG 无 FBSLM 监测的剖宫产分娩率有影响(分别为 25/61 和 28/62,P=0.64,风险比 0.91,95%置信区间 0.60-1.36)。CTG 组中有 1 例新生儿符合死亡或严重结局、新生儿脑病、5 分钟 Apgar 评分<4、新生儿复苏、入住新生儿重症监护病房 96 小时或以上的复合新生儿结局标准。

结论

我们无法提供 FBSLM 改善 CTG 在评估胎儿健康方面的特异性的有效性的有力证据。

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