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Publications

Omniview-SisPorto is a leader in the advancement of Computerized Analysis of the CTG.

Several scientific publications are published about about the sytem or have used it. In this page you can find a selection of such publications.


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 Page 1 of 2. Total articles: 9.

FM-ALERT: a randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring.

Inês Nunes, Diogo Ayres-de-Campos, Austin Ugwumadu, Pina Amin, Philip Banfield, Antony Nicoll, Simon Cunningham, Paulo Sousa, Cristina Costa-Santos, João Bernardes, for the FM-ALERT study group

RCT Results Presentation in ECIC 2015


Introduction: Cardiotocography (CTG) is widely used for intrapartum fetal monitoring, but its interpretation has limited interobserver agreement and the technology has not been shown to improve clinically important outcomes. Computer analysis incorporating real-time alerts for healthcare professionals has recently been developed as a reproducible alternative. This study was conducted to determine whether the use of this technology resulted in improved perinatal outcomes or reduced intervention rates.

Materials and Methods: This multicentre randomised clinical trial was carried out in five hospitals in the United Kingdom. Inclusion criteria were: women aged =16 years, able to provide written informed consent, singleton pregnancies =36 weeks, cephalic presentation, no known major fetal malformations, in labour but excluding active second stage, planned for continuous CTG monitoring, and no known contra-indication for vaginal delivery. Eligible women were randomised using a computer-generated sequence to one of two arms: computer analysis of fetal monitoring signals with real-time alerts using the Omniview-SisPorto® 3.5 system (Speculum®, Lisbon, Portugal) or CTG monitoring as previously performed (control arm). ST analysis and fetal scalp blood sampling were available in both arms. The primary outcome was the incidence of newborn metabolic acidosis (valid paired samples with umbilical artery pH < 7.05 and BDecf >12 mmol/L). Secondary outcomes were cesarean section rates, instrumental vaginal delivery rates, use of fetal blood sampling, 5-minute Apgar score < 7, neonatal intensive care unit admission, moderate and severe neonatal hypoxic-ischemic encephalopathy and perinatal death. Analysis followed an intention to treat principle.

Results: A total of 7730 cases were enrolled, 3961 were randomised to the experimental arm and 3769 to the control arm. Fourteen cases were lost to follow-up (0.18%) and 7 patients opted out of the study before birth (0.09%). Cord blood gas values were available in 87.0% of cases. No significant differences in baseline characteristics occurred between the two groups. Newborn metabolic acidosis occurred in 0.40% of cases in the experimental arm and 0.58% of those in the control arm (RR=0.69 [0.36-1.31]). No significant differences between the groups were found in cesarean section rates (20.4% vs. 20.5%, RR=1.00 [0.91,1.09]), instrumental vaginal delivery rates (31.6% vs. 29.5%, RR=1.07 [1.00-1.14], random effects model RR=1.02 [0.84-1.24]), use of fetal blood sampling (6.1% vs. 5.6%, RR=1.09 [0.91-1.30]), 5-minute Apgar score < 7 (1.2% vs. 1.4%, RR=0.86 [0.58-1.27]), neonatal intensive care unit admission (3.5% vs. 3.8%, RR=0.91 [0.72-1.15]), moderate and severe neonatal hypoxic-ischemic encephalopathy (0.13% vs. 0.03%, RR=4.76 [0.56-40.70]), or perinatal death (0.025% vs. 0%).


Conclusion: Access to computer analysis of CTGs resulted in the lowest incidence of newborn metabolic acidosis ever reported in randomised controlled trials, but the difference was not statistically significant. The incidence of the primary outcome was much lower than expected, suggesting that the study was underpowered to detect such differences. Intervention rates were similar in both arms.

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Access to computerised analysis of intrapartum cardiotocographs improves clinicians' prediction of newborn umbilical artery blood pH.

Costa A, Santos C, Ayres-de-Campos D, Costa C, Bernardes J.

BJOG. 2010 Sep;117(10):1288-93. Epub 2010 Jul 7.


OBJECTIVE: To evaluate the impact of access to computerised cardiotocograph (CTG) analysis on reproducibility and accuracy of clinicians' predictions of umbilical artery blood pH (UAB pH) and 5-minute Apgar score. DESIGN: Prospective evaluation of pre-recorded cases. SETTING: A tertiary-care university hospital. POPULATION: From databases of intrapartum CTGs acquired in singleton term pregnancies, 204 tracings with low signal loss and short time interval to delivery were consecutively selected. METHODS: Tracings were randomly assigned to computer analysis by the Omniview-SisPorto 3.5 system (study group n = 104) or to no analysis (control group n = 100). Three experienced clinicians evaluated all tracing printouts independently and were asked to predict the newborns' UAB pH and 5-minute Apgar scores from them. MAIN OUTCOME MEASURES: Interobserver agreement (measured by the intraclass correlation coefficient [ICC]) and accuracy in prediction of neonatal outcomes with 95% CI. RESULTS: Agreement on prediction of UAB pH was significantly higher in the study group (ICC = 0.70; 95% CI 0.61-0.77) than in the control group (ICC = 0.43; 95% CI 0.21-0.60), and a trend towards better agreement was also seen in estimation of 5-minute Apgar scores (ICC = 0.55; 95% CI 0.38-0.68 versus ICC = 0.43; 95% CI 0.25-0.57). Observers predicted UAB pH values correctly within a 0.10 margin in 70% of cases in the study group (95% CI 0.61-0.79) versus 46% in the control group (95% CI 0.35-0.56). They predicted 5-minute Apgar scores within a margin of one in 81% of cases in the study group (95% CI 0.73-0.88) and in 70% of cases in the control group (95% CI 0.61-0.79). CONCLUSIONS: Prediction of UAB pH is more reproducible and accurate when clinicians have access to computerised analysis of CTGs.
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Impact of the introduction of central fetal monitoring with computerised analysis and real-time alerts on the rates of caesarean section and adverse neonatal outcome

Joana Amaral, Antónia Costa, Cristina Santos, Diogo Ayres de Campos, João Bernardes

Prize for best oral communication awarded by Professor Sir Arulkumaran


Objectives: To evaluate the impact of the introduction of central fetal monitoring with computerised analysis and real-time alerts in the labour of a tertiary care university hospital, on the rates of caesarean section and adverse neonatal outcomes. Methods : Retrospective quantification of the number of deliveries, overall caesarean section rate, intrapartum caesarean section rate for non-reassuring fetal state (NRFS), and newborn with the diagnosis of hypoxic ischemic encephalopathy (HIE) of probable intrapartum origin, that occurred between January 2001 and December 2008, having central monitoring been introduced in the second half of 2003. Results : In the period 2001-2003 8791 deliveries occurred, the overall caesarean section rate was 30.2% (95%CI=29.0-31.1), while between 2004-2008 13191 occurred and the overall caesarean rate was 29.3% (95%CI=28.2-29.8). In 2001-2003 the caesarean section rate for NTFS were 18.3% (95%CI=16.5-19.5), in 2004-2008 it was significantly lower at 14.4% (95%CI=12.9-15.1). The mean number of yearly cases of HIE per 1000 deliveries was 5,9% (95%CI=3.7-4.3) in 2001-2003 and 2.5% (95%CI=1.2-4.6) in 2004-2008. Conclusions: The introduction of centralised fetal monitoring with computerised analysis and real-time alerts, in the labour ward of a tertiary care hospital was associated with a significant reduction in caesarean section rates due to NRFS and yearly rates of HIE. However, it is not possible to guarantee a causal relation between these events, as other phenomena occurred during this period, which could have also contributed to the decrease incidence of these outcomes.

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Sex differences in linear and complex fetal heart rate dynamics of normal and acidemic fetuses in the minutes preceding delivery.

Bernardes J, Gonçalves H, Ayres-de-Campos D, Rocha AP.

J Perinat Med. 2009;37(2):168-76.

AIM: To assess linear and complex heart rate dynamics in relation to fetal gender in normal and acidemic fetuses during the minutes preceding delivery. METHODS: Linear and non-linear fetal heart rate indices, namely mean FHR, long-term irregularity index, short-term variability, low and high frequency spectral indices, approximate and sample entropy, were assessed in 36 female and 30 male fetuses, adjusted for gestational age and weight, during the minutes preceding delivery. Analysis was performed in the initial and final minutes of each tracing in fetuses with umbilical artery blood pH at delivery >or=7.20, 7.11-7.19 and CONCLUSIONS: During the minutes preceding delivery, female fetuses express higher linear indices than male fetuses, suggesting greater activation of the autonomic nervous system, while maintaining similar complexity indices, which suggests different reaction and adaptation capabilities to stress and distress.
Link to article online

Prediction of neonatal acidemia by computer analysis of fetal heart rate and ST event signals.

Costa A, Ayres-de-Campos D, Costa F, Santos C, Bernardes J.

Am J Obstet Gynecol. 2009 Nov;201(5):464.e1-6. Epub 2009 Jun 18.

OBJECTIVE: The objective of the study was to evaluate the accuracy of computer analysis of fetal heart rate (FHR) and ST event signals in prediction of neonatal acidemia. STUDY DESIGN: One hundred forty-eight FHR tracings were evaluated to identify red alerts provided by the system, based on automated analysis of FHR and ST event signals, and compared with the occurrence of umbilical artery acidemia (pH < or =7.05). RESULTS: The presence of red alerts obtained sensitivity of 1.00 (95% confidence interval [CI], 0.56-1.00), specificity of 0.94 (95% CI, 0.89-0.97), positive predictive value (PPV) of 0.47 (95% CI, 0.22-0.72), negative predictive value (NPV) of 1 (95% CI, 0.96-1.00), positive likelihood ratio (PLR) of 17.6 (95% CI, 9.0-34.5), and negative likelihood ratio (NLR) of 0. When limiting analysis to red alerts that did not include ST data, sensitivity was 0.57 (95% CI, 0.20-0.88), specificity was 0.97 (95% CI, 0.92-0.99), PPV was 0.50 (95% CI, 0.17-0.82), NPV was 0.98 (95% CI, 0.93-0.99), PLR was 20.14 (95% CI, 6.3-64.2), and NLR was 0.44 (95% CI, 0.19-1.04). CONCLUSION: Computer analysis of FHR and ST event signals provide higher accuracy in predicting neonatal academia.
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Linear and complex heart rate dynamics vary with sex in relation to fetal behavioural states.

Bernardes J, Gonçalves H, Ayres-de-Campos D, Rocha AP.

Early Hum Dev. 2008 Jul;84(7):433-9. Epub 2008 Jan 14.

BACKGROUND: A better understanding of gender influences on fetal heart rate can help to improve analysis of the latter and perhaps elucidate the increased risk of perinatal death that occurs in males. AIM: To assess differences in linear and complex heart rate dynamics according to fetal sex, in the antepartum period of normal term pregnancies, for patterns associated with fetal behavioural states. STUDY DESIGN AND SUBJECTS: One hundred and eighty seven fetal heart rate segments of 10-minute duration, acquired with a system for computerized analysis of cardiotocograms and classified into fetal behavioural patterns A, B, C or D were analysed. They had been acquired from 24 female and 23 male term fetuses, with uneventful perinatal outcomes. Four different comparative studies between female and male fetuses were conducted, considering different adjustments for gestational age, weight and FHR pattern. OUTCOME MEASURES: Indices of linear and nonlinear fetal heart rate variability, namely, long-term irregularity index, very low, low and high frequency spectral indices, approximate entropy and sample entropy. RESULTS: Pattern B was the most frequent, both in female and male fetuses. Pattern A was more likely to be associated to female than male fetuses, whereas the opposite occurred with patterns C and D. Linear indices were significantly higher in male than in female fetuses, whereas the opposite occurred with nonlinear indices. CONCLUSIONS: Male fetuses exhibited significantly more linear and significantly less complex fetal heart rate activity than female fetuses, expressing signs of a more active autonomous nervous system and of less active complexity control systems. These aspects may need to be considered when interpreting FHR tracings.
Link to article online

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