Search

Objective: To estimate the effectiveness of intrapartum fetal monitoring by cardiotocography plus ST analysis using a strict protocol for performance of fetal blood sampling.Methods: We performed a multicenter randomized trial among laboring women with a high-risk singleton pregnancy in cephalic presentation beyond 36 weeks of gestation. Participants were assigned to monitoring by cardiotocography with ST analysis (index) or cardiotocography only (control). Primary outcome was metabolic acidosis, defined as an umbilical cord artery pH below 7.05 combined with a base deficit calculated in the extracellular fluid compartment above 12 mmol/L. Secondary outcomes were metabolic acidosis in blood, operative deliveries, Apgar scores, neonatal admissions, and hypoxic-ischemic encephalopathy.Results: We randomly assigned 5,681 women to the two groups (2,832 index, 2,849 control). The fetal blood sampling rate was 10.6% in the index compared with 20.4% in the control group (relative risk 0.52; 95% [CI] 0.46-0.59). The primary outcome occurred 0.7% in the index compared with 1.1% in the control group (relative risk 0.70; 95% CI 0.38-1.28; number needed to treat 252). Using metabolic acidosis calculated in blood, these rates were 1.6% and 2.6%, respectively (relative risk 0.63; 95% CI 0.42-0.94; number needed to treat 100). The number of operative deliveries, low Apgar scores, neonatal admissions, and newborns with hypoxic-ischemic encephalopathy was comparable in both groups.Conclusion: Intrapartum monitoring by cardiotocography combined with ST analysis does not significantly reduce the incidence of metabolic acidosis calculated in the extracellular fluid compartment. It does reduce the incidence of metabolic acidosis calculated in blood and the need for fetal blood sampling without affecting the Apgar score, neonatal admissions, hypoxic-ischemic encephalopathy, or operative deliveries.Level Of Evidence: I. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to assess the effectiveness of electronic fetal monitoring (EFM) alone and with additional ST analysis (EFM + ST) in laboring women with a singleton term pregnancy that is in cephalic presentation in the prevention of metabolic acidosis by the application of individual patient data metaanalysis., Study Design: We conducted an individual patient data metaanalysis using data from 4 randomized trials, which enabled us to account for missing data and investigate relevant subgroups. The primary outcome was metabolic acidosis, which was defined as an umbilical cord-artery pH <7.05 and a base deficit that had been calculated in the extra cellular fluid compartment >12 mmol/L. We performed 8 explanatory subgroup analyses for 8 different endpoints., Results: We analyzed data from 12,987 women and their newborn infants. Metabolic acidosis was present in 57 women (0.9%) in the EFM + ST group and 73 women (1.1%) in the EFM alone group (relative risk [RR], 0.76; 95% CI, 0.53-1.10). Compared with EFM alone, the use of EFM + ST resulted in a reduction in the frequency of instrumental vaginal deliveries (RR, 0.90; 95% CI, 0.83-0.99) and fetal blood samples (RR, 0.49; 95% CI, 0.44-0.55). Cesarean delivery rates were comparable between both groups (RR, 0.99; 95% CI, 0.91-1.09). Subgroup analyses showed that EFM + ST resulted in fewer admissions to a neonatal intensive care unit for women with a duration of pregnancy of >41 weeks (RR, 0.61; 95% CI, 0.39-0.95)., Conclusion: EFM + ST does not reduce the risk of metabolic acidosis, but it does reduce the need for instrumental vaginal deliveries and fetal blood sampling., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Objective: To assess substandard care factors in the case of delivery-related asphyxia., Design: Prospective cohort study., Setting: Catchment area of the Neonatal Intensive Care Unit (NICU) of the University Medical Center Utrecht; a region in the middle of the Netherlands covering 13% of the Dutch population., Population: Term infants, without congenital malformations, who died intrapartum or were admitted to the Neonatal Intensive Care Unit due to asphyxia., Methods: During a two-year period, cases were prospectively collected and audited by an expert panel., Main Outcome Measures: Substandard care factors., Results: 37 735 term infants without congenital malformations were born. There were 19 intrapartum deaths, and 89 NICU admissions of which 12 neonates died. In 63 (58%) cases a substandard care factor was identified that was possibly (n= 47, 43%) or probably (n= 16, 15%) related to perinatal death or NICU admission. In primary care, substandard care factors were mainly the low frequency of examination during labor and delay in referral to secondary care. In secondary care, misinterpretation of cardiotocography and failure to respond adequately to clinical signs of fetal distress were the most common substandard care factors., Conclusions: Substandard care is present in a substantial number of cases with delivery-related asphyxia resulting in perinatal death or NICU admission. Improving the organization of obstetric care in the Netherlands as well as training of obstetric caregivers might reduce adverse outcomes., (© 2012 The Authors © 2012 Nordic Federation of Societies of Obstetrics and Gynecology.)

Objective: To investigate the association between maternal intrapartum fever and ST-waveform changes of the fetal electrocardiogram., Design: Retrospective cohort study., Setting: Three academic and six non-academic teaching hospitals in the Netherlands., Population: Labouring women with a high-risk singleton pregnancy in cephalic position beyond 36 weeks of gestation., Methods: We studied 142 women with fever (≥38.0°C) during labour and 141 women with normal temperature who had been included in two previous studies. In both groups, we counted the number and type of ST-events and classified them as significant (intervention needed) or not significant, based on STAN(®) clinical guidelines., Main Outcome Measures: Number and type of ST-events., Results: Both univariable and multivariable regression analysis showed no association between the presence of maternal intrapartum fever and the number or type of ST-events., Conclusions: Maternal intrapartum fever is not associated with ST-segment changes of the fetal electrocardiogram. Interpretation of ST-changes in labouring women with fever should therefore not differ from other situations., (© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.)

Objective: To evaluate whether correct adherence to clinical guidelines might have led to prevention of cases with adverse neonatal outcome., Design: Secondary analysis of cases with adverse outcome in a multicenter randomized clinical trial., Setting: Nine Dutch hospitals., Population: Pregnant women with a term singleton fetus in cephalic position., Methods: Data were obtained from a randomized trial that compared monitoring by STAN® (index group) with cardiotocography (control group). In both trial arms, three observers independently assessed the fetal surveillance results in all cases with adverse neonatal outcome, to determine whether an indication for intervention was present, based on current clinical guidelines., Main Outcome Measures: Adverse neonatal outcome cases fulfilled one or more of the following criteria: (i) metabolic acidosis in umbilical cord artery (pH < 7.05 and base deficit in extracellular fluid >12 mmol/L); (ii) umbilical cord artery pH < 7.00; (iii) perinatal death; and/or (iv) signs of moderate or severe hypoxic ischemic encephalopathy., Results: We studied 5681 women, of whom 61 (1.1%) had an adverse outcome (26 index; 35 control). In these women, the number of performed operative deliveries for fetal distress was 18 (69.2%) and 16 (45.7%), respectively. Reassessment of all 61 cases showed that there was a fetal indication to intervene in 23 (88.5%) and 19 (57.6%) cases, respectively. In 13 (50.0%) vs. 11 (33.3%) cases, respectively, this indication occurred more than 20 min before the time of delivery, meaning that these adverse outcomes could possibly have been prevented., Conclusions: In our trial, more strict adherence to clinical guidelines could have led to additional identification and prevention of adverse outcome., (© 2012 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology.)

Objective: To predict instrumental vaginal delivery or caesarean section for suspected fetal distress or failure to progress., Design: Secondary analysis of a randomised trial., Setting: Three academic and six non-academic teaching hospitals in the Netherlands., Population: 5667 labouring women with a singleton term pregnancy in cephalic presentation., Methods: We developed multinomial prediction models to assess the risk of operative delivery using both antepartum (model 1) and antepartum plus intrapartum characteristics (model 2). The models were validated by bootstrapping techniques and adjusted for overfitting. Predictive performance was assessed by calibration and discrimination (area under the receiver operating characteristic), and easy-to-use nomograms were developed., Main Outcome Measures: Incidence of instrumental vaginal delivery or caesarean section for fetal distress or failure to progress with respect to a spontaneous vaginal delivery (reference)., Results:   375 (6.6%) and 212 (3.6%) women had an instrumental vaginal delivery or caesarean section due to fetal distress, and 433 (7.6%) and 571 (10.1%) due to failure to progress, respectively. Predictors were age, parity, previous caesarean section, diabetes, gestational age, gender, estimated birthweight (model 1) and induction of labour, oxytocin augmentation, intrapartum fever, prolonged rupture of membranes, meconium stained amniotic fluid, epidural anaesthesia, and use of ST-analysis (model 2). Both models showed excellent calibration and the receiver operating characteristics areas were 0.70-0.78 and 0.73-0.81, respectively., Conclusion:   In Dutch women with a singleton term pregnancy in cephalic presentation, antepartum and intrapartum characteristics can assist in the prediction of the need for an instrumental vaginal delivery or caesarean section for fetal distress or failure to progress., (© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.)

We sought to predict neonatal metabolic acidosis at birth using antepartum obstetric characteristics (model 1) and additional characteristics available during labor (model 2). In 5667 laboring women from a multicenter randomized trial that had a high-risk singleton pregnancy in cephalic presentation beyond 36 weeks of gestation, we predicted neonatal metabolic acidosis. Based on literature and clinical reasoning, we selected both antepartum characteristics and characteristics that became available during labor. After univariable analyses, the predictors of the multivariable models were identified by backward stepwise selection in a logistic regression analysis. Model performance was assessed by discrimination and calibration. To correct for potential overfitting, we (internally) validated the models with bootstrapping techniques. Of 5667 neonates born alive, 107 (1.9%) had metabolic acidosis. Antepartum predictors of metabolic acidosis were gestational age, nulliparity, previous cesarean delivery, and maternal diabetes. Additional intrapartum predictors were spontaneous onset of labor and meconium-stained amniotic fluid. Calibration and discrimination were acceptable for both models (c-statistic 0.64 and 0.66, respectively). In women with a high-risk singleton term pregnancy in cephalic presentation, we identified antepartum and intrapartum factors that predict neonatal metabolic acidosis at birth., (Copyright © 2012 by Thieme Medical Publishers, Inc.)

Objective: To evaluate the added value of the baseline T/QRS ratio to other known risk factors in predicting adverse outcome and interventions for suspected fetal distress., Design: Prospective cohort study., Setting: Three academic and six non-academic teaching hospitals in the Netherlands., Population: Laboring women with a high-risk cephalic singleton pregnancy beyond 36 weeks of gestation., Methods: We obtained STAN(®) recordings (ST-analysis, Neoventa, Sweden) from two previous studies. Three patient groups were defined: cases with adverse outcome, cases with emergency delivery because of suspected fetal distress without adverse outcome, and a reference group of uncomplicated cases. Baseline T/QRS ratios among the adverse outcome and intervention for suspected fetal distress cases were compared to those of the uncomplicated cases. The ability of baseline T/QRS to predict adverse outcome and suspected fetal distress was determined using a multivariable logistic model., Main Outcome Measures: The added value of the baseline T/QRS to other known risk factors in the prediction of adverse outcome and interventions for suspected fetal distress., Results: From 3462 recordings, 2459 were available for analysis. Median baseline T/QRS for uncomplicated cases, adverse outcome and interventions for suspected fetal distress were 0.12 (range 0.00-0.52), 0.12 (0.00-0.42) and 0.13 (0.00-0.39), respectively. There was no statistical difference between these groups. Multivariable analysis showed no added value of baseline T/QRS in the prediction of either adverse outcome or interventions for suspected fetal distress., Conclusion: Baseline T/QRS has no added value in the prediction of adverse neonatal outcome or interventions for suspected fetal distress., (© 2012 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology.)

Objective: To evaluate the influence of intrapartum epidural analgesia on the occurrence of ST events of the fetal ECG., Design: Nested case-control study., Setting: Single-centre academic hospital in the Netherlands., Population: Laboring women with a high-risk singleton pregnancy in cephalic position beyond 36 weeks of gestation., Methods: Data of 72 women who received epidural analgesia using bupivacaine combined with sufentanil and 72 control women were collected and analyzed. The moment of epidural infusion was defined as t(0) . In the control group, t(0) was defined by matching dilatation in centimeters. STAN registrations from one hour before until two hours after t(0) were classified, and the numbers and types of ST events were recorded and judged according to the STAN clinical guidelines. T/QRS ratios were collected from one hour before t(0) until two hours after t(0) , and differences were compared between the two groups., Main Outcome Measures: Numbers and types of ST events and mean T/QRS ratios before and after t(0)., Results: There were no significant differences between cases and control women regarding the numbers of ST events, types of ST events and whether they were significant (intervention advised) or not. Correction for outliers (three cases and three control women) did not change the results. Differences of T/QRS ratios before and after t(0) were comparable between cases and control women., Conclusions: Epidural analgesia has no effect on the numbers or types of ST events when using ST analysis of the fetal ECG., (© 2011 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2011 Nordic Federation of Societies of Obstetrics and Gynecology.)

Objective: To assess the cost-effectiveness of addition of ST analysis of the fetal electrocardiogram (ECG; STAN) to cardiotocography (CTG) for fetal surveillance during labor compared with CTG only., Design: Cost-effectiveness analysis based on a randomized clinical trial on ST analysis of the fetal ECG., Setting: Obstetric departments of three academic and six general hospitals in The Netherlands. Population. Laboring women with a singleton high-risk pregnancy, a fetus in cephalic presentation, a gestational age >36 weeks and an indication for internal electronic fetal monitoring., Methods: A trial-based cost-effectiveness analysis was performed from a health-care provider perspective., Main Outcome Measures: Primary health outcome was the incidence of metabolic acidosis measured in the umbilical artery. Direct medical costs were estimated from start of labor to childbirth. Cost-effectiveness was expressed as costs to prevent one case of metabolic acidosis., Results: The incidence of metabolic acidosis was 0.7% in the ST-analysis group and 1.0% in the CTG-only group (relative risk 0.70; 95% confidence interval 0.38-1.28). Per delivery, the mean costs per patient of CTG plus ST analysis (n= 2 827) were €1,345 vs. €1,316 for CTG only (n= 2 840), with a mean difference of €29 (95% confidence interval -€9 to €77) until childbirth. The incremental costs of ST analysis to prevent one case of metabolic acidosis were €9 667., Conclusions: The additional costs of monitoring by ST analysis of the fetal ECG are very limited when compared with monitoring by CTG only and very low compared with the total costs of delivery., (© 2011 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2011 Nordic Federation of Societies of Obstetrics and Gynecology.)

Unlabelled: In a recently published randomized clinical trial on intrapartum fetal monitoring, fetal blood samples were obtained in 879 women. One serious complication of fetal blood sampling (FBS) was reported, a case in which physical examination of the neonate after delivery revealed clear fluid loss from the incision site. Four layers of the scalp appeared to be incised. The subarachnoid space was closed with 2 sutures, and antibiotics were started due to the risk of meningitis. The patient was discharged in good clinical condition. In this article, the case is presented and the literature reviewed. We found 12 articles reporting 37 cases of a complication due to FBS, none concerning leakage of cerebrospinal fluid. In conclusion, complications of FBS are rare but can be serious. Excessive fetal bleeding is most frequently reported and often associated with an underlying coagulopathy in the neonate., Target Audience: Obstetricians & Gynecologists, Family Physicians., Learning Objectives: After completion of this educational activity, the obstetrician/gynecologist should be better able to assess the chance of possible complications due to fetal blood sampling; select fetuses at risk for complications due to fetal blood sampling; and evaluate certain technical precautions when performing this procedure.

Objective: The objective of this study was to quantify inter- and intra-observer agreement on classification of the intrapartum cardiotocogram (CTG) and decision to intervene following STAN guidelines., Design: A prospective, observational study., Setting: Obstetrics Department of a tertiary referral hospital., Population: STAN recordings of 73 women after 36 weeks of gestation with a high-risk pregnancy, induced or oxytocin-augmented labour, meconium-stained amniotic fluid or epidural analgesia., Methods: Six observers classified 73 STAN recordings and decided if and when they would suggest an intervention. Proportions of specific agreement (Ps) and kappa values (Kappa) were calculated., Main Outcome Measures: Agreement upon classification of the intrapartum CTG and decision to perform an intervention., Results: Agreement for classification of a normal and a (pre)terminal CTG was good (Ps range 0.50-0.84), but poor for the intermediary and abnormal CTG (Ps range 0.34-0.56). Agreement on the decision to intervene was higher, especially on the decision to perform 'no intervention' (Ps range 0.76-0.94). Overall inter-observer agreement on the decision to intervene was considered moderate in five of six observer combinations according to the kappa (Kappa range 0.42-0.73). Intra-observer agreement for CTG classification and decision to intervene was moderate (Kappa range 0.52-0.67 and 0.61-0.75)., Conclusions: Inter-observer agreement on classification of the intrapartum CTG is poor, but addition of information regarding fetal electrocardiogram, especially in case of intermediary or abnormal CTG traces, results in a more standardised decision to intervene.

Since the 1970s, intrapartum monitoring of the distressed foetus has been managed by continuous registration of the foetal heart rate, together with uterine activity (cardiotocogram; CTG). Use of CTG without additional foetal information leads to unnecessary interventions because of the high number of false-positive signals. Foetal blood sampling (FBS) is a solution to this problem, but is not always consistently carried out. Automated ST analysis of the foetal electrocardiogram (STAN method), combined with the CTG, may lead to reduction of metabolic acidosis, fewer interventions and fewer foetal blood samples. A disadvantage of application of the STAN method is that it is based on visual interpretation of the CTG, with large inter- and intraobserver variability. In spite of this shortcoming the method may be promising.

Objective: To examine detailed intrapartum events in cases of neonatal metabolic acidosis despite monitoring using STAN (cardiotocography [CTG] plus ST waveform analysis of fetal electrocardiogram [ECG])., Design: Retrospective case review., Setting: High-risk pregnancies monitored by STAN., Methods: Case note review was performed in newborns with metabolic acidosis where no significant ST changes in the fetal ECG occurred prior to birth., Main Outcome Measures: Metabolic acidosis., Results: Detailed review of three cases identified poor signal quality, difficulties in CTG interpretation, failure to comply with STAN clinical guidelines and deterioration of the CTG without ECG alert as the leading causes of these adverse outcomes., Conclusions: The cases illustrate some of the pitfalls associated with the clinical application of the STAN technology which prevent severe metabolic acidosis being eradicated completely. It may be useful to expand the STAN guidelines protocol towards the identification of exceptional clinical situations, such as in our cases, and towards appropriate additional interventions, as this may lead to a further reduction in adverse neonatal outcomes.

Background: Cardiotocography (CTG) is worldwide the method for fetal surveillance during labour. However, CTG alone shows many false positive test results and without fetal blood sampling (FBS), it results in an increase in operative deliveries without improvement of fetal outcome. FBS requires additional expertise, is invasive and has often to be repeated during labour. Two clinical trials have shown that a combination of CTG and ST-analysis of the fetal electrocardiogram (ECG) reduces the rates of metabolic acidosis and instrumental delivery. However, in both trials FBS was still performed in the ST-analysis arm, and it is therefore still unknown if the observed results were indeed due to the ST-analysis or to the use of FBS in combination with ST-analysis., Methods/design: We aim to evaluate the effectiveness of non-invasive monitoring (CTG + ST-analysis) as compared to normal care (CTG + FBS), in a multicentre randomised clinical trial setting. Secondary aims are: 1) to judge whether ST-analysis of fetal electrocardiogram can significantly decrease frequency of performance of FBS or even replace it; 2) perform a cost analysis to establish the economic impact of the two treatment options. Women in labour with a gestational age > or = 36 weeks and an indication for CTG-monitoring can be included in the trial. Eligible women will be randomised for fetal surveillance with CTG and, if necessary, FBS or CTG combined with ST-analysis of the fetal ECG. The primary outcome of the study is the incidence of serious metabolic acidosis (defined as pH < 7.05 and Bdecf > 12 mmol/L in the umbilical cord artery). Secondary outcome measures are: instrumental delivery, neonatal outcome (Apgar score, admission to a neonatal ward), incidence of performance of FBS in both arms and cost-effectiveness of both monitoring strategies across hospitals. The analysis will follow the intention to treat principle. The incidence of metabolic acidosis will be compared across both groups. Assuming a reduction of metabolic acidosis from 3.5% to 2.1 %, using a two-sided test with an alpha of 0.05 and a power of 0.80, in favour of CTG plus ST-analysis, about 5100 women have to be randomised. Furthermore, the cost-effectiveness of CTG and ST-analysis as compared to CTG and FBS will be studied., Discussion: This study will provide data about the use of intrapartum ST-analysis with a strict protocol for performance of FBS to limit its incidence. We aim to clarify to what extent intrapartum ST-analysis can be used without the performance of FBS and in which cases FBS is still needed., Trial Registration Number: ISRCTN95732366.