Computerised interpretation of the fetal heart rate during labour: a randomised controlled trial (INFANT)
Computerised interpretation of the fetal heart rate during labour: a randomised controlled trial (INFANT)
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DOI：
10.3310/hta22090
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发表时间：
2018-02-01
影响因子：
3.6
通讯作者：
Rivero-Arias, Oliver
中科院分区：
文献类型：
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作者：
Brocklehurst, Peter;Field, David;Rivero-Arias, Oliver
背景：连续电子胎儿监护 (EFM) 在分娩中得到广泛应用，计算机化解读有可能提高其实用性。 目的：本试验旨在查明添加决策支持软件来协助解读胎心宫缩图 (CTG) 是否可以减少不良新生儿结局的数量，以及是否具有成本效益。 设计： 两臂单独随机对照试验。分配是使用可变块大小的分层块随机化由计算机生成的。该试验未进行掩盖。地点：英格兰、苏格兰和爱尔兰共和国的产房。参与者：妊娠≥35周、单胎或双胎妊娠、进行 EFM 的产妇。干预措施：决策支持或无决策支持。主要结局指标：主要结局指标为 (1) 新生儿不良结局{产时死产或新生儿早期死亡（不包括致命先天性异常）或新生儿发病率的综合结果[定义为新生儿脑病 (NNE)]，或在 48 小时内入住新生儿病房并持续≥ 48 小时（有喂养困难、呼吸系统疾病的证据，或当有出生时受损的证据时为 NNE）}； (2) 对幸存儿童子集在 2 岁时进行发育评估。 结果：2010 年 1 月 6 日至 2013 年 8 月 31 日期间，47,062 名妇女被随机分组，46,042 名妇女被纳入主要分析（决策支持组 22,987 名，无决策支持组 23,055 名）。短期主要结局事件发生率高于预期。没有证据表明各组之间的新生儿不良结局发生率存在差异：决策支持组中的婴儿为 0.7% (n = 172)，而无决策支持组中的婴儿为 0.7% (n = 171) [调整后风险比 1.01，95% 置信区间 (CI) 0.82 至 1.25]。没有证据表明《儿童能力家长报告修订版》的长期主要结局存在差异，决策支持组平均得分为 98.0 分 [标准差 (SD) 33.8 分]，无决策支持组平均得分为 97.2 分 (SD 33.4 分)（平均差 0.63 分，95% CI -0.98 至 2.25 分）。没有发现卫生资源使用和总成本存在差异的证据。有证据表明决策支持确实改变了实践（增加了胎儿血液采样和降低了重复警报率）。 局限性：对照组的工作人员可能会从试验的决策支持组中学习，从而改善对照组的结果。这是在规划阶段就确定的，并且认为不太可能对结果产生重大影响。由于这是一项务实的试验，因此对 CTG 警报的响应留给了主治临床医生。 结论：该试验不支持这样的假设：在分娩时进行 EFM 的妇女中使用 CTG 的计算机解释可以改善母亲或婴儿的临床结果。
Background: Continuous electronic fetal monitoring (EFM) in labour is widely used and computerised interpretation has the potential to increase its utility.Objectives: This trial aimed to find out whether or not the addition of decision support software to assist in the interpretation of the cardiotocograph (CTG) reduced the number of poor neonatal outcomes, and whether or not it was cost-effective.Design: Two-arm individually randomised controlled trial. The allocations were computer generated using stratified block randomisation employing variable block sizes. The trial was not masked.Setting: Labour wards in England, Scotland and the Republic of Ireland.Participants: Women in labour having EFM, with a singleton or twin pregnancy, at >= 35 weeks' gestation.Interventions: Decision support or no decision support.Main outcome measures: The primary outcomes were (1) a composite of poor neonatal outcome {intrapartum stillbirth or early neonatal death (excluding lethal congenital anomalies), or neonatal morbidity [defined as neonatal encephalopathy (NNE)], or admission to a neonatal unit within 48 hours for >= 48 hours (with evidence of feeding difficulties, respiratory illness or NNE when there was evidence of compromise at birth)}; and (2) developmental assessment at the age of 2 years in a subset of surviving children.Results: Between 6 January 2010 and 31 August 2013, 47,062 women were randomised and 46,042 were included in the primary analysis (22,987 in the decision support group and 23,055 in the no decision support group). The short-term primary outcome event rate was higher than anticipated. There was no evidence of a difference in the incidence of poor neonatal outcome between the groups: 0.7% (n = 172) of babies in the decision support group compared with 0.7% (n = 171) of babies in the no decision support group [adjusted risk ratio 1.01, 95% confidence interval (CI) 0.82 to 1.25]. There was no evidence of a difference in the long-term primary outcome of the Parent Report of Children's Abilities-Revised with a mean score of 98.0 points [standard deviation (SD) 33.8 points] in the decision support group and 97.2 points (SD 33.4 points) in the no decision support group (mean difference 0.63 points, 95% CI -0.98 to 2.25 points). No evidence of a difference was found for health resource use and total costs. There was evidence that decision support did change practice (with increased fetal blood sampling and a lower rate of repeated alerts).Limitations: Staff in the control group may learn from exposure to the decision support arm of the trial, resulting in improved outcomes in the control arm. This was identified in the planning stage and felt to be unlikely to have a significant effect on the results. As this was a pragmatic trial, the response to CTG alerts was left to the attending clinicians.Conclusions: This trial does not support the hypothesis that the use of computerised interpretation of the CTG in women who have EFM in labour improves the clinical outcomes for mothers or babies.