4 Development, evaluation and validation of an intelligent system for the management of labour

Keith, Robert; Greene, Kate

doi:10.1016/s0950-3552(05)80200-7

Cited by 35 publications

(25 citation statements)

References 16 publications

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“…Computer analysis of CTGs was introduced in the 1980s [9,17,21,24] in an attempt to overcome the subjectivity of visual analysis [3,29] . The fi rst systems were developed for antepartum monitoring, where increased baseline stability, lower signal loss and artefacts and reduced tracing length pose less challenges for signal processing and algorithm development.…”

Section: Discussionmentioning

confidence: 99%

“…This system was developed at the University of Plymouth by the Perinatal Research Group [24] . It allows the display of several CTG tracings and ST data on the same computer screen, visible in multiple locations.…”

Section: Guardian Tm and Infant ® (K2 Medical Systems Tm Plymouth Uk)mentioning

confidence: 99%

“…A retrospective blinded study, evaluating the analysis provided by a previous version of the system in 30 high-risk labours was published in 1994 [25] . At the time, the system recommended management actions, and these were compared with those of three experienced clinicians and with the actual clinical decision.…”

Section: Guardian Tm and Infant ® (K2 Medical Systems Tm Plymouth Uk)mentioning

confidence: 99%

See 2 more Smart Citations

An overview of central fetal monitoring systems in labour

Nunes¹,

Ayres-de-Campos²,

Figueiredo

et al. 2012

Journal of Perinatal Medicine

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A variety of systems for centralised viewing of fetal signals during labour are currently available, allowing simultaneous monitoring of multiple tracings in one or more locations. Display of maternal vital signs, ST signals and an electronic partogram are available in the majority of these systems. A few of them have incorporated computer analysis of cardiotocographic signals or combined cardiotocographic and ST data analysis. Computer analysis may elicit real-time alerts for healthcare professionals when changes associated with fetal hypoxia are detected. Central fetal monitoring systems have been installed in a large number of maternity hospitals in industrialised countries, but there is still limited evidence of their impact on perinatal indicators, on the behaviour of healthcare professionals and on related health costs.

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Section: Discussionmentioning

confidence: 99%

Section: Guardian Tm and Infant ® (K2 Medical Systems Tm Plymouth Uk)mentioning

confidence: 99%

Section: Guardian Tm and Infant ® (K2 Medical Systems Tm Plymouth Uk)mentioning

confidence: 99%

See 1 more Smart Citation

An overview of central fetal monitoring systems in labour

Nunes¹,

Ayres-de-Campos²,

Figueiredo

et al. 2012

Journal of Perinatal Medicine

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“…Three studies conducted by the Plymouth group [35][36][37] demonstrated that the software, when used 'offline', performed as well as expert obstetricians in interpreting the CTG and managing labour subsequently, and that the system performed better than routine clinical practice. The system identified more cases that went on to have a poor outcome and anticipated clinical decision-making.…”

Section: Studies Using the Intelligent Support Softwarementioning

confidence: 99%

“…[35][36][37] However, the alerts do not take into account other information about the labour, such as the duration of labour, the rate of labour progress, presence of meconium, whether or not the woman has an elevated temperature and whether or not there is suspected fetal growth restriction, all of which may modify the way a clinician interprets the fetal heart rate and acts on this information. Further development of decision support software to include these variables may improve the quality of the feedback the system provides to clinicians and therefore may make a positive difference to outcomes.…”

Section: Value Of This Researchmentioning

confidence: 99%

Computerised interpretation of the fetal heart rate during labour: a randomised controlled trial (INFANT)

Brocklehurst

Field

Greene

et al. 2018

Health Technol Assess

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BackgroundContinuous electronic fetal monitoring (EFM) in labour is widely used and computerised interpretation has the potential to increase its utility.ObjectivesThis 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.DesignTwo-arm individually randomised controlled trial. The allocations were computer generated using stratified block randomisation employing variable block sizes. The trial was not masked.SettingLabour wards in England, Scotland and the Republic of Ireland.ParticipantsWomen in labour having EFM, with a singleton or twin pregnancy, at ≥ 35 weeks’ gestation.InterventionsDecision support or no decision support.Main outcome measuresThe 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.ResultsBetween 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).LimitationsStaff 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.ConclusionsThis 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.Future workThere continues to be an urgent need to improve knowledge and training about the appropriate response to CTG abnormalities, including timely intervention.Trial registrationCurrent Controlled Trials ISRCTN98680152.FundingThis project was funded by the National Institute for Health Research (NIHR) HTA programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 9. See the NIHR Journals Library website for further project information. Sara Kenyon was part funded by the NIHR Collaboration for Leadership in Applied Health Research and Care West Midlands.

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Relation of fetal heart rate signals with unassignable baseline to poor neonatal state at birth

Georgieva

Payne

Moulden

et al. 2012

Med Biol Eng Comput

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Electronic fetal heart rates (FHR) are used to monitor fetal health during labour. The paper records are visually assessed by clinicians, but automated alternatives are being developed. Interpretation, visual or computerised, depends on assigning a baseline to identify key features such as accelerations and decelerations. However, when the FHR is unstable the baseline may be unassignable, making conventional analysis unreliable. Such instability may reflect on fetal health. If true, these segments should not be discarded but quantified, for which we have developed a numerical method. In 7,568 labours, the association between unassignable baseline and umbilical arterial blood pH ≤ 7.05 at birth (evidence of poor health) was studied retrospectively. We found a consistent increase of the risk for acidaemia with longer intervals of unassignable baseline. This is detectable at the end of the first stage of labour, but stronger at the end of the second stage: in the last 30 min of labour, the odds ratios (with respect to baseline assignable throughout this period) increased from 1.99 (15 min unassignable) to 4.9 (30 min unassignable). Computerised analysis of the FHR becomes unreliable when the baseline cannot be assigned; however, this pattern is itself a pathological feature associated with acidaemia at birth.

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4 Development, evaluation and validation of an intelligent system for the management of labour

Cited by 35 publications

References 16 publications

An overview of central fetal monitoring systems in labour

An overview of central fetal monitoring systems in labour

Computerised interpretation of the fetal heart rate during labour: a randomised controlled trial (INFANT)

Relation of fetal heart rate signals with unassignable baseline to poor neonatal state at birth

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