New FIGO and Swedish intrapartum cardiotocography classification systems incorporated in the fetal ECG ST analysis (STAN) interpretation algorithm: agreements and discrepancies in cardiotocography classification and evaluation of significant ST events.

INTRODUCTION: The updated intrapartum cardiotocography (CTG) classification system by FIGO in 2015 (FIGO2015) and the FIGO2015-approached classification by the Swedish Society of Obstetricians and Gynecologist in 2017 (SSOG2017) are not harmonized with the fetal ECG ST analysis (STAN) algorithm from 2007 (STAN2007). The study aimed to reveal homogeneity and agreement between the systems in classifying CTG and ST events, and relate them to maternal and perinatal outcomes. MATERIAL AND METHODS: Among CTG traces with ST events, 100 traces originally classified as normal, 100 as suspicious and 100 as pathological were randomly selected from a STAN database and classified by two experts in consensus. Homogeneity and agreement statistics between the CTG classifications were performed. Maternal and perinatal outcomes were evaluated in cases with clinically hidden ST data (n = 151). A two-tailed p < 0.05 was regarded as significant. RESULTS: For CTG classes, the heterogeneity was significant between the old and new systems, and agreements were moderate to strong (proportion of agreement, kappa index 0.70-0.86). Between the new classifications, heterogeneity was significant and agreements strong (0.90, 0.92). For significant ST events, heterogeneities were significant and agreements moderate to almost perfect (STAN2007 vs. FIGO2015 0.86, 0.72; STAN2007 vs. SSOG2017 0.92, 0.84; FIGO2015 vs. SSOG2017 0.94, 0.87). Significant ST events occurred more often combined with STAN2007 than with FIGO2015 classification, but not with SSOG2017; correct identification of adverse outcomes was not significantly different between the systems. CONCLUSION: There are discrepancies in the classification of CTG patterns and significant ST events between the old and new systems. The clinical relevance of the findings remains to be shown.

Association between umbilical cord artery pCO2 and the Apgar score; elevated levels of pCO2 may be beneficial for neonatal vitality after moderate acidemia.

OBJECTIVE: To determine the association between 5-min Apgar score and umbilical cord artery carbon dioxide tension (pCO2). DESIGN: Observational study. SETTING: European hospital labor wards. POPULATION: Data from 36,432 newborns ≥36 gestational weeks were obtained from three sources: two trials of monitoring with fetal electrocardiogram (the Swedish randomized controlled trial and the European Union Fetal ECG trial) and Mölndal Hospital data. After validation of the acid-base values, 25,806 5-min Apgar scores were available for analysis. METHODS: Validation of the umbilical cord acid-base values was performed to obtain reliable data. 5-min Apgar score was regressed against cord artery pCO2 in a polynomial multilevel model. MAIN OUTCOME MEASURES: Five-min Apgar score, umbilical cord pCO2, pH, and base deficit. RESULTS: Overall, a higher cord artery pCO2 was found to be associated with lower 5-min Apgar scores. However, among newborns with moderate acidemia, lower umbilical cord artery pCO2 (≤median pCO2 for the specific cord artery pH) was associated with lower 5-min Apgar scores, with a relative risk of 2.0 (95% confidence interval: 1.4-2.8) for 5-min Apgar scores 0-6. CONCLUSIONS: Metabolic acidosis affects the newborn's vitality more than respiratory acidosis. In addition, elevated levels of pCO2 may be beneficial for fetuses with moderate acidemia, and thus cord artery pCO2 is a factor that should be considered when assessing the compromised newborn.

How does the duration of active pushing in labor affect neonatal outcomes?

AIM: To assess the effect of time of active pushing (TAP) on neonatal outcome. MATERIALS AND METHODS: The study population (n=36,432) was taken from a Swedish randomized control trial on intrapartum monitoring, a European Union fetal electrocardiogram trial, and from Mölndal Hospital. After validation of acid-base samples and TAP, 22,812 cases were accepted for analysis. RESULTS: The median active TAP was 36 min for P0 and 13 min for P≥1 (P<0.001). After adjustments for parity, epidural, labor induction, birth weight, and gender, pushing for 15-29 min (n=6589) relative to pushing for <15 min (n=7264) increased the OR of a cord artery pH of <7.00 to 3.20 (95% CI 1.7-6.0), and that of a base deficit in extracellular fluid of >12 mmol/L to 3.5 (95% CI 1.3-9.0). The group with a cord artery pH of <7.00 had a longer TAP than the group with pH≥7.00: median (5th-95th percentile), 38 (9-107) min vs. 23 (5-87) min, P<0.001. The probability of a spontaneous vaginal delivery decreased significantly with every subsequent increase of 30 min in TAP (P<0.05). CONCLUSION: The risks of severe acidemia, metabolic acidosis, and deteriorated neonatal outcome gradually increased with the length of TAP (>15 min), while the probability of a spontaneous vaginal delivery decreased with the duration of pushing. We suggest active physiological evaluation of the labor progress together with continuous electronic fetal monitoring during pushing irrespective of guideline thresholds.

Reduced prevalence of metabolic acidosis at birth: an analysis of established STAN usage in the total population of deliveries in a Swedish district hospital.

OBJECTIVE: The purpose of this study was to investigate quality-of-care improvements after the introduction of ST waveform analysis as an adjunct to standard cardiotocography (CTG). STUDY DESIGN: This was a prospective clinical study that was conducted over 7 years. Four yearly cohorts of 12,832 term pregnancies were part of a detailed analysis. Cord blood metabolic acidosis and neonatal outcome were main outcome measures. RESULTS: The STAN (S31 Fetal Heart Monitor; Neoventa Medical AB, Mölndal, Sweden) usage rate increased from 26 to 69%. The cord metabolic acidosis rate was reduced from 0.72 to 0.06%. This 91.7% improvement was associated with a significant reduction in the number of cases with a prolonged response time, calculated as the time from CTG + ST indications to intervene until delivery and an ability of the staff to identify and act on preterminal and unstable fetal heart rate patterns at the onset of a recording. CONCLUSION: Our data indicate a paradigm shift in the outcome of delivery related to a high rate of CTG + ST usage and the application of structured CTG analysis.

Identifying newborns with umbilical cord blood metabolic acidosis by intrapartum cardiotography combined with fetal ECG ST analysis (STAN): comparison of the new and old FIGO systems to classify cardiotocograms.

Introduction: The intrapartum cardiotocography (CTG) classification system by FIGO in 2015 (FIGO2015) was introduced to simplify CTG interpretation, but it is not harmonized with the fetal ECG ST analysis (STAN) algorithm from 2007 (STAN2007), which is based on the FIGO CTG system from 1987. The study aimed to determine time courses and sensitivity between the systems in classifying CTG + ST events to indicate metabolic acidosis at birth.Material and methods: Forty-four cases with umbilical cord artery metabolic acidosis were retrieved from a European multicenter database. CTG patterns and timing of the first occurring significant ST events were evaluated post hoc in consensus by an expert panel and sensitivity statistics were performed. Wilcoxon's matched-pairs signed-ranks test and McNemar's test were used with a two-tailed p < .05 regarded significant.Results: STAN2007 had a higher sensitivity (73 versus 43%, p = .0002) and alarmed for metabolic acidosis in mean 34 min earlier than the FIGO2015 system did (p = .002). In every fourth case, the time difference was ≥20 min.Conclusions: In this simulation study, surveillance with STAN2007 combined with fetal ECG ST analysis had a significantly higher sensitivity and would have alarmed for metabolic acidosis significantly earlier than the new FIGO system would have.

FHR patterns that become significant in connection with ST waveform changes and metabolic acidosis at birth.

Introduction: Recent developments have produced new CTG classification systems and the question is to what extent these may affect the model of FHR + ST interpretation? The two new systems (FIGO2015 and SSOG2017) classify FHR + ST events differently from the current CTG classification system used in the STAN interpretation algorithm (STAN2007). Aim: Identify the predominant FHR patterns in connection with ST events in cases of cord artery metabolic acidosis missed by the different CTG classification systems. Indicate to what extent STAN clinical guidelines could be modified enhancing the sensitivity. Provide a pathophysiological rationale. Material and methods: Forty-four cases with umbilical cord artery metabolic acidosis were retrieved from a European multicenter database. Significant FHR + ST events were evaluated post hoc in consensus by an expert panel. Results: Eighteen cases were not identified as in need of intervention and regarded as negative in the sensitivity analysis. In 12 cases, ST changes occurred but the CTG was regarded as reassuring. Visual analysis of the FHR + ST tracings revealed specific FHR patterns: Conclusion: These findings indicate FHR + ST analysis may be undertaken regardless of CTG classification system provided there is a more physiologically oriented approach to FHR assessment in connection with an ST event.

STAN in clinical practice--the outcome of 2 years of regular use in the city of Gothenburg.

OBJECTIVE: The purpose of this study was to monitor the introduction of the STAN-methodology (Noventa Medical, Moelndal, Sweden). STUDY DESIGN: This was a prospective observational study covering the total population of deliveries at term during 2 years. Four thousand eight hundred and thirty out of 14,687 term pregnancies were monitored using the STAN S 21 fetal heart monitor and the associated clinical guidelines. Cord artery metabolic acidosis, neonatal outcome, and rates of operative deliveries for fetal distress were assessed. RESULTS: The annual rate of STAN usage increased from 28.1% to 37.7% and was associated with a significant reduction in metabolic acidosis rate in the total population from 0.76% to 0.44% (P < .05). The compliance with the clinical guidelines increased in cases requiring intervention. The rates for moderate/severe hypoxic neonatal encephalopathy were consistently low, 0.55 and 0.68 per 1000 deliveries, respectively, and corresponding to previous findings. The rate of operative delivery did not change during the 2 years in the total population. CONCLUSION: Increasing STAN usage provided consistent improvements in fetal outcome equalling those noted in the Swedish randomized controlled trial (RCT) without increasing operative interventions for fetal distress.

United States multicenter clinical usage study of the STAN 21 electronic fetal monitoring system.

OBJECTIVE: The fetal electrocardiogram system for electronic fetal monitoring (EFM) (STAN S21, Neoventa Medical, Moelndal, Sweden) has led to improved perinatal outcomes in other countries. We aimed to assess the ability of United States (US) obstetricians to use this system appropriately for intrapartum care. STUDY DESIGN: A prospective nonrandomized trial was conducted in 6 sites. Enrollment required a singleton vertex fetus, >36 weeks' gestation, with indications for direct fetal monitoring during first stage of labor. Appropriate use was measured by negative predictive value (NPV) of nonintervention for fetuses with nonreassuring fetal heart rate (FHR) patterns, normal STAN readings, and normal neonatal outcomes with umbilical cord arterial pH >7.12; and percent agreement (PA) for intervention decisions with 3 STAN experts who conducted retrospective case reviews blinded to outcome. RESULTS: Five hundred and thirty patients were enrolled. An NPV of 95.2% was achieved while PA between investigators and STAN experts was 84%, and 90%, for intervention and nonintervention, respectively. No fetus with metabolic acidosis requiring intervention was missed by US clinicians. CONCLUSION: US clinicians used the STAN system appropriately in a manner similar to that of experienced STAN users.

Fetal ECG waveform analysis.

Fetal ECG waveform analysis as an adjunct to electronic fetal monitoring (EFM) has developed over the last 3 decades. From a multitude of potential parameters, ST waveform analysis has been documented to provide the information required to shift EFM from a screening device to a diagnostic tool that meets the standards of evidence-based medicine. This chapter details the experimental and clinical evolution of the STAN methodology for intrapartum fetal surveillance. Observational data formed the basis for cardiotocograph (CTG) and ST waveform analysis clinical guidelines. Data from two large, randomized controlled trials (6826 cases) are summarized together with the first analysis of the recently completed EU project of 7823 term fetuses monitored as part of the study to introduce ST analysis into clinical practice. The reduction in the incidence of newborns with marked neurological symptoms is supported by these findings. The detection of ST changes allowed earlier and more consistent intervention.

Real-time PCR-assay in the delivery suite for determination of group B streptococcal colonization in a setting with risk-based antibiotic prophylaxis.

OBJECTIVE: Intrapartum antibiotic prophylaxis (IAP) reduces the incidence of neonatal early onset group B streptococcal infections. The present study investigated if an automated PCR-assay, used bedside by the labor ward personnel was manageable and could decrease the use of IAP in a setting with a risk-based IAP strategy. METHODS: The study comprises two phases. Phase 1 was a multicenter, randomized, controlled trial. Women with selected risk-factors were allocated either to PCR-IAP (prophylaxis given if positive or indeterminate) or IAP. A vaginal/rectal swab and superficial swabs from the neonate for conventional culture were also obtained. Phase 2 was non-randomized, assessing an improved version of the assay. RESULTS: Phase 1 included 112 women in the PCR-IAP group and 117 in the IAP group. Excluding indeterminate results, the assay showed a sensitivity of 89% and a specificity of 90%. In 44 % of the PCR assays the result was indeterminate. The use of IAP was lower in the PCR group (53 versus 92%). Phase 2 included 94 women. The proportion of indeterminate results was reduced (15%). The GBS colonization rate was 31%. CONCLUSION: The PCR assay, in the hands of labor ward personnel, can be useful for selection of women to which IAP should be offered.

Developmental outcome at 6.5 years after acidosis in term newborns: a population-based study.

OBJECTIVES: Infants who develop encephalopathy after perinatal asphyxia have an increased risk of death and adverse neurologic outcome. Conflicting results exist concerning outcome in healthy infants with metabolic acidosis at birth. The aim of the current study was to evaluate whether metabolic acidosis at birth in term infants who appear healthy is associated with long-term developmental abnormalities. METHODS: From a population-based cohort (14,687 deliveries), 78 infants were prospectively identified as having metabolic acidosis (umbilical artery pH < 7.05 and base deficit in the extracellular fluid >12.0 mmol/L). Two matched controls per case were selected. The child health and school health care records were scrutinized for developmental abnormalities. RESULTS: Outcome measures at 6.5 years of age for 227 of 234 children (97%) were obtained. No differences were found concerning neurologic or behavioral problems in need of referral action or neurodevelopmental diagnosis in comparison of control children with acidotic children who had appeared healthy at birth, ie, had not required special neonatal care or had no signs of encephalopathy. CONCLUSIONS: Infants born with cord metabolic acidosis and who appear well do not have an increased risk for neurologic or behavioral problems in need of referral actions or special teaching approaches at the age of 6.5 years.

STAN, a clinical audit: the outcome of 2 years of regular use in the city of Varberg, Sweden.

OBJECTIVE: To monitor and analyze (audit) the introduction of the STAN methodology in a district hospital. DESIGN: Retrospective study covering the total population of deliveries at term during 2004 and 2005. MATERIAL AND METHODS: 1,875 out of 3,193 term pregnancies (59%) were monitored using the STAN fetal heart monitor (Neoventa Medical, Moelndal, Sweden) and the associated clinical guidelines. Cord metabolic acidosis, neonatal outcome, and rates of operative deliveries for fetal distress were recorded. RESULTS: The overall cesarean section rate was significantly reduced in the STAN group. Emergency (crash) cesarean sections were significantly reduced from 1.51% to 0.27% in the cardiotocography- and STAN-monitored groups, respectively (OR 0.18, 95% CI 0.07-0.49). When cesarean section was performed only because of non-reassuring cardiotocography, cord acid base was significantly higher, 7.26 versus 7.19 (p<0.01), as compared to when STAN guidelines were followed. Total population rates for operative deliveries for fetal distress and cesarean section rates were 6.7% and 3.5% respectively. The corresponding metabolic acidosis rate was 0.5%. CONCLUSION: High STAN usage in a busy labor ward setting provided an outcome equaling that noted previously in a larger academic unit, demonstrating the safe implementation of the STAN methodology in a nonacademic unit.

Fetal scalp pH and ST analysis of the fetal ECG as an adjunct to cardiotocography to predict fetal acidosis in labor--a multi-center, case controlled study.

OBJECTIVE: To assess the relationship between scalp pH (FBS) and ST analysis in situations of acidosis with special emphasis on the timing of cardiotocography (CTG), FBS and ST changes during labor. STUDY DESIGN: From a European Union multicenter study on clinical implementation of the STAN methodology, 911 cases were identified where a scalp-pH had been obtained. In 53 cases, marked cord artery acidosis was found (cord artery pH<7.06) and 44 cases showed moderate acidemia at birth (pH 7.06-7.09). Comparisons were made with 97 control cases (pH>or=7.20). RESULTS: Of those cases with FHR+ST events recorded within 16 min of delivery, 61% (17/28) had a cord artery pH>or=7.20. The corresponding figure for cases where STAN indications occurred for more than 16 min was 19% (13/69) (OR 6.66, 2.53-17.55, P<0.001). Out of the 121 cases with an abnormal CTG, 84 (69%) showed a cord artery pH of <7.10. STAN indicated abnormality in 83% (70 out of 84). The corresponding figure for scalp pH<7.20 was 43% (36/84). In the case of CTG changes at the start of an adequate recording STAN guidelines provided information on developing acidosis in all cases but one (16 out of 17) in the marked acidosis group. STAN guidelines indicated abnormality prior to an abnormal FBS in 14 out of 17 cases. The median duration between STAN indications to intervention and an abnormal FBS was 29 (95% CI 11-74) min. CONCLUSIONS: ST analysis, as an adjunct to CTG, identifies adverse fetal conditions during labor similar to that of FBS but on a more consistent basis. The timing of CTG+ST changes relates to the level of acidosis at birth.

Fetal electrocardiography in labor and neonatal outcome: data from the Swedish randomized controlled trial on intrapartum fetal monitoring.

OBJECTIVE: Cardiotocography plus automatic ST analysis of the fetal electrocardiography has been shown recently to reduce both the operative delivery rate for fetal distress and the cord artery metabolic acidosis rate. The purpose of this study was to analyze findings that were related to cases with a complicated/adverse neonatal outcome in the Swedish randomized controlled trial. STUDY DESIGN: Of the 4966 term fetuses that were included in the trial, all 351 newborn infants who required special neonatal care were identified. Cases of perinatal death, neonatal encephalopathy, or metabolic acidosis at birth were reviewed. RESULTS: Of the 29 fetuses with adverse/complicated neonatal outcome, 22 fetuses had cardiotocography and ST patterns that indicated a need for intervention, according to the cardiotocography plus ST clinical guidelines. The number of live-born with moderate or severe neonatal encephalopathy showed a significant decrease from 0.33% (8/2447 fetuses) in the cardiotocography-only group to 0.04% (1/2519 fetuses) in the cardiotocography plus ST group. CONCLUSION: Cardiotocography plus ST analysis provides accurate information about intrapartum hypoxia and may prevent intrapartum asphyxia and neonatal encephalopathy by giving a clear alert to the staff members who are in charge.

Fetal scalp pH and ST analysis of the fetal ECG as an adjunct to CTG. A multi-center, observational study.

OBJECTIVE: To evaluate the relationships between scalp-pH and CTG plus ST waveform analysis of the fetal ECG (STAN) clinical guidelines as indicators of intrapartum hypoxia in term fetuses born with cord artery acidemia. STUDY DESIGN: Data from 6999 term deliveries monitored by the STAN (R) S 21 as part of an EU multi-center study on clinical implementation of the STAN methodology for intrapartum fetal surveillance were analyzed. We identified 911 cases where a scalp-pH was obtained, including 53 cases with cord artery acidemia (pH < 7.06). Lag times between ST events and scalp-pH and time to delivery were related to cord artery metabolic and respiratory acidosis and neonatal outcome. RESULTS: 43 fetuses were identified by CTG plus ST as being in need of intervention 31 (25-46) minutes before delivery (median, 95% Cl). In five, no indications were given and in another five there were inadequate data. Fifteen cases with metabolic acidosis required special neonatal care, all 14 cases adequately monitored on STAN had indications to intervene for 19 minutes or more. In 30 adequately recorded cases, fetal blood sampling (FBS) was obtained within the last hour of labor. In 22 cases, FBS was obtained 13 (7-24) minutes after STAN guidelines had indicated abnormality and in eight no ST changes had occurred at time of FBS. The corresponding FBS data were pH 7.10 (7.01-7.15) and pH 7.21 (7.08-7.31), respectively, P = 0.01. In cases of metabolic acidosis, scalp-pH fell 0.01 units per minute after a baseline T/QRS rise was recorded during the second stage of labor. Apart from one newborn that died at 2 h from E. Coli septicemia, none of the neonates were affected neurologically. CONCLUSION: Cardiotocography plus ST analysis provides accurate information about intrapartum hypoxia similar to that obtained by scalp-pH.