Implementation of a revised classification for intrapartum fetal heart rate monitoring and association to birth outcome: A national cohort study.

INTRODUCTION: A revised intrapartum cardiotocography (CTG) classification was introduced in Sweden in 2017. The aims of the revision were to adapt to the international guideline published in 2015 and to adjust the classification of CTG patterns to current evidence regarding intrapartum fetal physiology. This study aimed to investigate adverse neonatal outcomes before and after implementation of the revised CTG classification. MATERIAL AND METHODS: A before-and-after design was used. Cohort I (n = 160 210) included births from June 1, 2014 through May 31, 2016 using the former CTG classification, and cohort II (n = 166 558) included births from June 1, 2018 through May 31, 2020 with the revised classification. Data were collected from the Swedish Pregnancy and Neonatal Registers. The primary outcome was moderate to severe neonatal hypoxic ischemic encephalopathy (HIE 2-3). Secondary outcomes were birth acidemia (umbilical artery pH <7.05 and base excess < -12 mmol/L or pH <7.00), A-criteria for neonatal hypothermia treatment, 5-min Apgar scores <4 and <7, neonatal seizures, meconium aspiration, neonatal mortality and delivery mode. Logistic regression was used (period II vs period I), and results are presented as adjusted odds ratios (aORs) with 95% confidence intervals (95% CIs). RESULTS: There were no statistically significant differences in HIE 2-3 (aOR 1.27; 95% CI 0.97-1.66), proportion of neonates meeting A-criteria for hypothermia treatment (aOR 0.96; 95% CI 0.89-1.04) or neonatal mortality (aOR 0.68; 95% CI 0.39-1.18) between the cohorts. Birth acidemia (aOR 1.36; 95% CI 1.25-1.48), 5-min Apgar scores <7 (aOR 1.27; 95% CI 1.18-1.36) and <4 (aOR 1.40; 95% CI 1.17-1.66) occurred more often in cohort II. The absolute risk difference for HIE 2-3 was 0.02% (95% CI 0.00-0.04). Operative delivery (vacuum or cesarean) rates were lower in cohort II (aOR 0.82; 95% CI 0.80-0.85 and aOR 0.94; 95% CI 0.91-0.97, respectively). CONCLUSIONS: Although not statistically significant, a small increase in the incidence of HIE 2-3 after implementation of the revised CTG classification cannot be excluded. Operative deliveries were fewer but incidences of acidemia and low Apgar scores were higher in the latter cohort. This warrants further in-depth analyses before a full re-evaluation of the revised classification can be made.

The quality of intrapartum cardiotocography in preterm labour.

OBJECTIVES: The aim of this study is to determine the quality of the foetal heart rate (FHR) recording, defined as signal loss, during preterm labour below 28 weeks gestational age (GA) and contribute to the discussion if cardiotocography (CTG) is of value for the extreme preterm foetus. METHODS: From January 2010 to December 2019 a retrospective study was conducted with data of 95 FHR recordings of singletons born between 24 and 28 weeks GA at the Amsterdam University Medical Centre, location VUmc. FHR tracings had a duration of at least 30 min and were obtained via external ultrasound mode. Data of all recordings were divided in two groups according to gestation (24-26 weeks and 26-28 weeks). Signal loss was analysed. Statistical significance was calculated by non-parametric tests and chi-square tests. The median signal loss and the proportion of cases exceeding the International Federation of Gynaecology and Obstetrics Guidelines (FIGO) threshold of 20% signal loss were calculated. RESULTS: One-third of the recordings exceeded the 20% FIGO-criterion for adequate signal quality during the first stage of labour. In the second stage, this was nearly 75%. Similarly, the median signal loss was 13% during the first and 30% during the second stage of labour (p<0.01). CONCLUSIONS: The quality of FHR monitoring in the extreme preterm foetus is inadequate in a large proportion of the foetuses, especially during the second stage. FHR monitoring is therefore controversial and should be used with caution.

Time to reconsider: Have the 2015 FIGO and 2017 Swedish intrapartum cardiotocogram classifications led us from Charybdis to Scylla?

In 2015, FIGO revised the 1987 intrapartum cardiotocography (CTG) classification (FIGO1987). A less radical FIGO2015 version was introduced in Sweden 2017 (SWE2017). Now, post hoc simulation studies show that FIGO2015 and SWE2017 are less reliable than (a modified) FIGO1987. FIGO2015 shows significantly better interobserver agreement for normal CTG traces than FIGO1987, but significantly worse for pathological traces. Agreements between templates are moderate to good, but different classifications of mainly variable decelerations and tachycardia cause significant heterogeneities. FIGO2015 shows insufficient sensitivity to identify fetal acidemia compared with FIGO1987. In connection with fetal electrocardiogram ST analysis, one study showed no template was superior in identifying fetal acidemia, but in a series of only academia, FIGO1987 had significantly higher sensitivity than FIGO2015 (73% vs. 43%) and set of an alarm for fetal acidemia considerably earlier. With SWE2017, operative interventions declined significantly in Sweden but several adverse neonatal outcomes increased significantly. It remains to investigate the development with FIGO2015.

Intrapartum Fetal Monitoring.

Continuous electronic fetal monitoring was developed to screen for signs of hypoxic-ischemic encephalopathy, cerebral palsy, and impending fetal death during labor. Because these events have a low prevalence, continuous electronic fetal monitoring has a false-positive rate of 99%. The widespread use of continuous electronic fetal monitoring has increased operative and cesarean delivery rates without improved neonatal outcomes, but its use is appropriate in high-risk labor. Structured intermittent auscultation is an underused form of fetal monitoring; when employed during low-risk labor, it can lower rates of operative and cesarean deliveries with neonatal outcomes similar to those of continuous electronic fetal monitoring. However, structured intermittent auscultation remains difficult to implement because of barriers in nurse staffing and physician oversight. The National Institute of Child Health and Human Development terminology is used when reviewing continuous electronic fetal monitoring and delineates fetal risk by three categories. Category I tracings reflect a lack of fetal acidosis and do not require intervention. Category II tracings are indeterminate, are present in the majority of laboring patients, and can encompass monitoring predictive of clinically normal to rapidly developing acidosis. Presence of moderate fetal heart rate variability and accelerations with absence of recurrent pathologic decelerations provides reassurance that acidosis is not present. Category II tracing abnormalities can be addressed by treating reversible causes and providing intrauterine resuscitation, which includes stopping uterine-stimulating agents, fetal scalp stimulation and/or maternal repositioning, intravenous fluids, or oxygen. Recurrent deep variable decelerations can be corrected with amnioinfusion. Category III tracings are highly concerning for fetal acidosis, and delivery should be expedited if immediate interventions do not improve the tracing.

A qualitative study of a sample of women participating in an Australian randomised controlled trial of intrapartum fetal surveillance.

BACKGROUND: The STan Australian Randomised controlled Trial (START), the first of its kind in Australia, compares two techniques of intrapartum fetal surveillance (cardiotocographic electronic fetal monitoring (CTG) plus analysis of the ST segment of the fetal electrocardiogram (STan+CTG) with CTG alone) with the aim of reducing unnecessary obstetric intervention. It is also the first comprehensive intrapartum fetal surveillance (IFS) trial worldwide, including qualitative examination of psychosocial outcomes and cost-effectiveness. In evaluating and implementing healthcare interventions, the perspectives and experiences of individuals directly receiving them is an integral part of a comprehensive assessment. Furthermore, the added value of using qualitative research alongside randomised controlled trials (RCTs) is becoming widely acknowledged. OBJECTIVE: This study aimed to examine women's experiences with the type of IFS they received in the START trial. METHODS: Using a qualitative research design, a sample of thirty-two women were interviewed about their experiences with the fetal monitoring they received. Data were analysed using thematic analysis. FINDINGS: Six themes emerged from analysis: reassurance, mobility, discomfort, perception of the fetal Scalp Electrode (FSE), and overall positive experience. CONCLUSION: Interestingly, it was found that women who had an FSE in the CTG alone arm of the trial reported very similar experiences to women in the STan+CTG arm of the trial. Despite STan and CTG differing clinically, from women's perspectives, the primary difference between the two techniques was the utilisation (or not) of the FSE. Women were very accepting of STan+CTG as it was perceived and experienced as a more accurate form of monitoring than CTG alone. Findings from this study have significant implications for health professionals including midwives and obstetricians and implications for standard practice and care. The study has demonstrated the importance and significance of incorporating qualitative enquiry within RCTs.

Use and experiences with external fetal monitoring devices among obstetrical providers.

Introduction: Fetal heart rate monitoring presents one of the few available methods for evaluating the fetus prior to birth. However, current devices on the market have significant shortcomings. We sought to describe the use and experiences with external fetal monitoring (EFM) devices among obstetrical providers.Materials and methods: We performed a cross-sectional survey in an academic medical center between April and July 2017 including nurse, midwife, and physician obstetrical providers (n = 217) who were invited to participate in this study regarding their experiences with the external fetal monitoring (EFM) device utilized by their hospital system in the outpatient, inpatient, and labor and delivery (L&D) settings. Associations between provider characteristics, device use, perception of challenging patients, and potential usefulness of an improved system were assessed by Fisher's exact test.Results: The 137 respondents (63.1%) reported difficulties monitoring obese women (98.5%), multiple gestation pregnancies (90.5%), and early gestational ages (71.5%). Over half (59.5%) of L&D nurses reported interacting with EFM devices for greater than 1-hour during a typical 12-hour shift and fewer than half (42.3%) reported being satisfied with current EFM devices. There were no statistically significant associations between provider age, experience, or time spent utilizing the devices with perception of challenging patient types.Conclusions: In conclusion, obstetrical providers perceive shortcomings of current EFM devices across all levels of provider experience and time utilizing these devices. Nurses reported significant time operating the devices, representing an opportunity to reduce time and costs with an improved device.

Types of intrapartum hypoxia on the cardiotocograph (CTG): do they have any relationship with the type of brain injury in the MRI scan in term babies?

Electronic foetal monitoring using cardiotocography is aimed at the timely recognition and management of foetal hypoxia. The primary objective of this study was to examine whether a relationship exists between the types of foetal hypoxia (acute, subacute, evolving, chronic), as identified on cardiotocography and the nature of hypoxic ischaemic encephalopathy, as observed on MRI scans after birth. We conducted a retrospective study of 16 babies born (out of 52,187 births) at St George's Hospital in London during 2006-2017 with a postnatal diagnosis of HIE. Of the 16 babies, only 11 had both MRI scans and CTG traces available. Of those, 9 showed evidence of intrapartum hypoxia on CTG, but only 6 demonstrated evidence of HIE on MRI. Those with acute hypoxia showed abnormalities in the basal ganglia and thalami. A gradually evolving hypoxia or subacute hypoxia was associated with lesions in myelination and cerebral cortex.Impact StatementWhat is already known on this subject? It has been reported that inter-observer agreement for CTG interpretation is low (30%) when pattern recognition based guidelines are used (Rhöse et al. 2014; Reif et al. 2016), even amongst 'experts' (Hruban et al. 2015). Furthermore, it has been shown that CTG traces do not reliably predict neonatal encephalopathy (Spencer et al. 1997).What do the results of this study add? Our study indicates that if 'types of intrapartum hypoxia' are used for interpretation, then inter-observer agreement increases to 81%, from the reported 30% when traces are classified into 'normal, suspicious and pathological' using guidelines based on 'pattern recognition'. Furthermore, our study shows a good correlation between the type of intrapartum hypoxia observed on CTG trace and the nature of injury observed on the MRI.What are the implications of these findings for clinical practise and/or further research? Improving inter-observer agreement of CTGs with the use of pattern recognition in combination with the good correlation to MRI scan findings ultimately leads to better management and post-natal outcomes. This is evidenced by the fact that after the introduction of physiology-based CTG interpretation and mandatory competency testing on CTG interpretation for all staff in 2010, St. George's Maternity Unit has half the nationally reported rate of cerebral palsy.

IMproving the practice of intrapartum electronic fetal heart rate MOnitoring with cardiotocography for safer childbirth (the IMMO programme): protocol for a qualitative study.

INTRODUCTION: Suboptimal electronic fetal heart rate monitoring (EFM) in labour using cardiotocography (CTG) has been identified as one of the most common causes of avoidable harm in maternity care. Training staff is a frequently proposed solution to reduce harm. However, current approaches to training are heterogeneous in content and format, making it difficult to assess effectiveness. Technological solutions, such as digital decision support, have not yet demonstrated improved outcomes. Effective improvement strategies require in-depth understanding of the technical and social mechanisms underpinning the EFM process. The aim of this study is to advance current knowledge of the types of errors, hazards and failure modes in the process of classifying, interpreting and responding to CTG traces. This study is part of a broader research programme aimed at developing and testing an intervention to improve intrapartum EFM. METHODS AND ANALYSIS: The study is organised into two workstreams. First, we will conduct observations and interviews in three UK maternity units to gain an in-depth understanding of how intrapartum EFM is performed in routine clinical practice. Data analysis will combine the insights of an ethnographic approach (focused on the social norms and interactions, values and meanings that appear to be linked with the process of EFM) with a systems thinking approach (focused on modelling processes, actors and their interactions). Second, we will use risk analysis techniques to develop a framework of the errors, hazards and failure modes that affect intrapartum EFM. ETHICS AND DISSEMINATION: This study has been approved by the West Midlands-South Birmingham Research Ethics Committee, reference number: 18/WM/0292. Dissemination will take the form of academic articles in peer-reviewed journals and conferences, along with tailored communication with various stakeholders in maternity care.

The impact of a national cardiotocography education program on neonatal and maternal outcomes: A historical cohort study.

INTRODUCTION: Studies indicate an association between errors in cardiotocography (CTG) management and hypoxic brain injuries among newborns. Continuing professional education is recommended. We aimed to examine whether the implementation of a national interprofessional CTG education program in Denmark was associated with a decrease in risk of fetal hypoxia measured by umbilical cord pH < 7.00, 5-minute Apgar score <7 or neonatal therapeutic hypothermia. As a secondary aim, we assessed whether the educational intervention was associated with an increase in operative deliveries. MATERIAL AND METHODS: We conducted a historical cohort study from 2009 to 2015 including all intended vaginal deliveries with liveborn singletons in cephalic presentation and gestational age ≥37 weeks. Data were retrieved from the Medical Birth Register and the National Patient Register. The study period was divided in three: pre-implementation (2009-2012), implementation (2013) and post-implementation (2014-2015). Using logistic regression we estimated odds ratios (OR) of fetal hypoxia outcomes using the pre-implementation period as reference. Analyses were adjusted for potential maternal, neonatal and delivery-associated confounders. Missing data were accounted for by multiple imputation. RESULTS: In all, 331 282 deliveries were included. Overall risks of pH < 7.00, Apgar score <7 and therapeutic hypothermia were respectively 0.45%, 0.58% and 0.06%. Adjusted OR in the post-implementation period were 1.12 (95% confidence interval [CI] 1.00-1.26), 0.99 (95% CI 0.90-1.10) and 1.34 (95% CI 0.99-1.82) for the three outcomes, respectively. The pH missingness equaled 12.4%. Odds of emergency cesarean section was unaltered, whereas the odds of assisted vaginal delivery decreased by 14% (0.86, 95% CI 0.84-0.89). CONCLUSIONS: Healthcare professionals are considered the weakest link of CTG technology. We did not find that increasing healthcare professionals' CTG interpretation skills affected the risk of fetal hypoxia. Missing data for pH values were substantial and represent a limitation of the study. We cannot with certainty rule out that missingness masked a true effect of the intervention. Our study indicates that assisted vaginal deliveries can be decreased without an increased risk of fetal hypoxia. Dilution of effect in a complex clinical setting, rare outcomes, insufficient intervention and a possible overestimation of the impact of errors in CTG management might explain the lack of effect.

Experiences and views of midwives performing antenatal cardiotocography in Dutch primary care: A qualitative study.

OBJECTIVE: In the current Dutch maternity care system, pregnant women who have an indication for an antenatal cardiotocography (CTG) to be undertaken need to be referred from primary midwife-led care to secondary obstetric-led care. Within three different regions in the Netherlands independent primary care midwives perform antenatal CTG in primary care, introduced as a pilot project. The aim of this study was to evaluate the experiences and views of primary care midwives who perform antenatal CTG in primary care. DESIGN: Using a qualitative approach data were collected by seventeen in depth semi-structured interviews. The interview recordings were transcribed verbatim and analysed using thematic coding. SETTING: Three regions in the Netherlands where midwives carry out antenatal CTG in primary care during this pilot project. PARTICIPANTS: Seventeen primary care midwives were interviewed between July and November 2017. FINDINGS: In general, midwives were satisfied with performing antenatal CTG and felt it contributed positively towards the midwife-client relationship. However, midwives experienced an increased workload, partly due to time-consuming technical difficulties. Furthermore, mixed feelings existed on whether antenatal CTG contributes to a more physiological or to a more pathological approach in midwifery practice. Most midwives believed that performing antenatal CTG contributes to the physiological process: strengthening of their gate-keeper role, increased confidence of their clients and improved midwife-client relationship. In contrast, some midwives believed it contributes to a pathological process: medicalization and relying too much on technical devices. KEY CONCLUSIONS: This study showed an overall positive attitude of primary care midwives towards performing antenatal CTG when required, in primary midwife-led care. However, performing the antenatal CTG can be a challenge for midwives, as midwifery care within this setting is often for healthy women who have a straightforward pregnancy. For some midwives, providing antenatal CTG monitoring in the primary care setting may be seen as using a pathological approach to midwifery care. IMPLICATIONS FOR PRACTICE: There seems to be a place for antenatal CTG in primary midwife-led care. However, further research is needed before this practice can be implemented widely.