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.

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.

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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